Lower risk Medical device recall · FDA · Published February 12, 2021

NuVasive PRECICE Unyte System: Not Approved for Children Under 18

NuVasive recalls PRECICE Unyte Humerus and Tibia trauma nail systems due to insufficient biological assessments for patients under 18. These devices are not indicated for use in individuals under 18 years old.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1350-2021Medical device NuVasive ›

Lower-risk recall

Due to not having the full complement of biological assessments for all potential patients and as a result the devices are not indicated for use in individuals under the age of 18 years old.

Take action

Contact the company

Recalling firmNuvasive Specialized Orthopedics Inc101 Enterprise Ste 100 · Aliso Viejo, CA 92656-2604

✎ GovInfoNow plain-language explainer

NuVasive is recalling its PRECICE Unyte Humerus and Tibia trauma nail systems because they were not properly tested for use in patients under 18 years old. This means these devices should not be used on children or teenagers. Read more at govinfonow.com/recall/63273-nuvasive-precice-unyte-system-not-approved-for-children-under-18.

Source Summary by GovInfoNow · govinfonow.com/recall/63273-nuvasive-precice-unyte-system-not-approved-for-children-under-18 · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1350-2021

Cite this page

“NuVasive PRECICE Unyte System: Not Approved for Children Under 18.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63273-nuvasive-precice-unyte-system-not-approved-for-children-under-18. Based on FDA recall #Z-1350-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1350-2021%22&limit=1).

The FDA announced on Feb. 12, 2021, that NuVasive Specialized Orthopedics Inc. is recalling the NUVASIVE PRECICE UNYTE System for humerus and tibia because the devices are not indicated for patients under 18 years old. The recall involves 229 units distributed worldwide.

How to tell if you have it

Brand: NuVasive
Product: NUVASIVE PRECICE UNYTE System (Humerus and Tibia): PRECICE Trauma Nail System/PRECICE Unyte-Humerus Orthopedic trauma
Lot codes: All Lots manufactured between April 2015 to February 2021

The hazard

The devices lack the full complement of biological assessments for all potential patients, resulting in them not being indicated for use in individuals under the age of 18 years old.

Context

NuVasive Specialized Orthopedics, Inc. has 6 other recalls on record since 2019-06-25. Other recent recalls include the NuVasive Precice Max Orthopedic Devices Recall (2024-09-30) and the NuVasive MAGEC 2 Rod Recall (2022-11-01). A 2021-10-29 update for the NuVasive Precice IMLL System also addressed age and weight limits.

How to tell if you have this one

Check for the PRECICE Unyte system with the listed product codes (e.g., CDH8.5-20L165 for humerus rods) or GTIN numbers provided in the recall. All units manufactured between April 2015 and February 2021 are affected.

Brand
NuVasive
Category
Medical device

FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Worldwide distribution, including U.S. Nationwide.

Recall number	Product, codes & lots	Quantity
Z-1349-2021	NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System End Cap for PRECICE Intramedullary Limb Lengthening System Implant; Packaged End Cap 8.5/10.7mm,¿ +0mm; Packaged End Cap 8.5/10.7mm,¿ +5mm; Packaged End Cap 8.5/10.7mm,¿ +10mm; Packaged End Cap 8.5/10.7mm,¿ +15mm; Packaged End Cap 8.5/10.7mm,¿ +20mm; Packaged End Cap 12.5mm,¿ +0mm; Packaged End Cap 12.5mm,¿ +5mm; Packaged End Cap 12.5mm,¿ +10mm; Packaged End Cap 12.5mm,¿ +15mm; Packaged End Cap 12.5mm,¿ +20mm; 3.5 mm Locking Screw, 20 mm Length; 3.5 mm Locking Screw 25 mm Length; 3.5 mm Locking Screw 30 mm Length; 3.5 mm Locking Screw 35 mm Length; 3.5 mm Locking Screw 40 mm Length; 3.5 mm Locking Screw 45 mm Length; 3.5 mm Locking Screw 50 mm Length; 3.5 mm Locking Screw 55 mm Length; 3.5 mm Locking Screw 60 mm Length; Locking Screw, 3.5x65mm; Locking Screw, 3.5x70mm; Locking Screw, 3.5x75mm; 4.0 mm Locking Screw 20 mm Length; 4.0 mm Locking Screw 25 mm Length; 4.0 mm Locking Screw 30 mm Length; 4.0 mm Locking Screw 35 mm Length; 4.0 mm Locking Screw 40 mm Length; 4.0 mm Locking Screw 45 mm Length; 4.0 mm Locking Screw 50 mm Length; 4.0 mm Locking Screw 55 mm Length; 4.0 mm Locking Screw 60 mm Length; 5.0 mm Locking Screw 20 mm Length; 5.0 mm Locking Screw 25 mm Length; 5.0 mm Locking Screw 30 mm Length; 5.0 mm Locking Screw 35 mm Length; 5.0 mm Locking Screw 40 mm Length; 5.0 mm Locking Screw 45 mm Length; 5.0 mm Locking Screw 50 mm Length; 5.0 mm Locking Screw 55 mm Length; 5.0 mm Locking Screw 60 mm Length; 5.0 mm Locking Screw 65 mm Length; 5.0 mm Locking Screw 70 mm Length; 5.0 mm Locking Screw 75 mm Length; 4.0 mm Locking Screw 20 mm Length; 4.0 mm Locking Screw 25 mm Length; 4.0 mm Locking Screw 30 mm Length; 4.0 mm Locking Screw 35 mm Length; 4.0 mm Locking Screw 40 mm Length; 4.0 mm Locking Screw 45 mm Length; 4.0 mm Locking Screw 50 mm Length; 4.0 mm Locking Screw 55 mm Length; 4.0 mm Locking Screw 60 mm Length; 4.0 mm X 65 mm Locking Screw, Peg; 4.0 mm X 70 mm Locking Screw, Peg; 4.0 mm X 75 mm Locking Screw, Peg; 4.0 mm X 80 mm Locking Screw, Peg; 4.0 mm X 85 mm Locking Screw, Peg; 4.0 mm X 90 mm Locking Screw, Peg; 4.0 mm X 95 mm Locking Screw, Peg; 4.0 mm X 100 mm Locking Screw, Peg; 5.0 mm Locking Screw 20 mm Length; 5.0 mm Locking Screw 25 mm Length; 5.0 mm Locking Screw 30 mm Length; 5.0 mm Locking Screw 35 mm Length; 5.0 mm Locking Screw 40 mm Length; 5.0 mm Locking Screw 45 mm Length; 5.0 mm Locking Screw 50 mm Length; 5.0 mm Locking Screw 55 mm Length; 5.0 mm Locking Screw 60 mm Length; 5.0 mm Locking Screw 65 mm Length; 5.0 mm Locking Screw 70 mm Length; 5.0 mm Locking Screw 75 mm Length; 5.0 mm X 80 mm Locking Screw, Peg; 5.0 mm X 85 mm Locking Screw, Peg; 5.0 mm X 90 mm Locking Screw, Peg; 5.0 mm X 95 mm Locking Screw, Peg; 5.0 mm X 100 mm Locking Screw, Peg; Orthopedic intramedullary limb lengthening rod, retrograde femur 10 degree, 10.7 mm diameter, 170 mm length; Orthopedic intramedullary limb lengthening rod, antegrade tibia, 10.7 mm diameter, 160 mm length; Orthopedic intramedullary limb lengthening rod, antegrade femur trochanteric, 10.7 mm diameter, 170 mm length; Orthopedic intramedullary limb lengthening rod, universal femur, 10.7 mm diameter, 170 mm length; Orthopedic intramedullary limb lengthening rod, retrograde femur, 10 degree, 10.7 mm diameter, 215 mm length; Orthopedic intramedullary limb lengthening rod, retrograde femur, 10 degree, 10.7 mm diameter, 230 mm length; Orthopedic intramedullary limb lengthening rod, antegrade femur (piriformis), 10.7 mm diameter, 215 mm length; Orthopedic intramedullary limb lengthening rod, antegrade femur (piriformis), 10.7 mm diameter, 230 mm length; Orthopedic intramedullary limb lengthening rod, antegrade tibia, 10.7 mm diameter, 195 mm length; Orthopedic intramedullary limb lengthening rod, antegrade tibia, 10.7 mm diameter, 215 mm length; Orthopedic intramedullary limb lengthening; All Lots manufactured between April 2015 to February 2021. PRECICE Intramedullary Limb Lengthening (IMLL) Product Codes: End caps: CPA1-000; CPA2-000; CPA2-005; CPA2-010; CPA2-015; CPA2-020; CPA3-000; CPA3-005; CPA3-010; CPA3-015; CPA3-020; Locking screws: LSB3-020; LSB3-025; LSB3-030; LSB3-035; LSB3-040; LSB3-045; LSB3-050; LSB3-055; LSB3-060; LSB3-065; LSB3-070; LSB3-075; LSB4-020; LSB4-025; LSB4-030; LSB4-035; LSB4-040; LSB4-045; LSB4-050; LSB4-055; LSB4-060; LSB5-020; LSB5-025; LSB5-030; LSB5-035; LSB5-040; LSB5-045; LSB5-050; LSB5-055; LSB5-060; LSB5-065; LSB5-070; LSB5-075; LSC4-020; LSC4-025; LSC4-030; LSC4-035; LSC4-040; LSC4-045; LSC4-050; LSC4-055; LSC4-060; LSC4-065; LSC4-070; LSC4-075; LSC4-080; LSC4-085; LSC4-090; LSC4-095; LSC4-100; LSC5-020; LSC5-025; LSC5-030; LSC5-035; LSC5-040; LSC5-045; LSC5-050; LSC5-055; LSC5-060; LSC5-065; LSC5-070; LSC5-075; LSC5-080; LSC5-085; LSC5-090; LSC5-095; LSC5-100; Limb lengthening intramedullary rods 10.7 mm diameter: P10.7-30H170; P10.7-30J160; P10.7-30K170; P10.7-30U170; P10.7-50A215; P10.7-50A230; P10.7-50B215; P10.7-50B230; P10.7-50C195; P10.7-50C215; P10.7-50C230; P10.7-50D215; P10.7-50D230; P10.7-50E215; P10.7-50E230; P10.7-50H190; P10.7-50J180; P10.7-50K190; P10.7-50M175; P10.7-50N160; P10.7-50P175; P10.7-50Q155; P10.7-50U190; P10.7-50V215; P10.7-50V230; P10.7-50X215; P10.7-50X230; P10.7-80A245; P10.7-80A275; P10.7-80A305; P10.7-80A335; P10.7-80A365; P10.7-80B245; P10.7-80B275; P10.7-80B305; P10.7-80B335; P10.7-80B365; P10.7-80C245; P10.7-80C275; P10.7-80C305; P10.7-80C335; P10.7-80C365; P10.7-80D245; P10.7-80D275; P10.7-80D305; P10.7-80D335; P10.7-80D365; P10.7-80E245; P10.7-80E275; P10.7-80E305; P10.7-80E335; P10.7-80E365; P10.7-80V245; P10.7-80V275; P10.7-80V305; P10.7-80V335; P10.7-80V365; P10.7-80X245; P10.7-80X275; P10.7-80X305; P10.7-80X335; P10.7-80X365; Limb lengthening intramedullary rods 12.5 mm diameter: P12.5-30H170; P12.5-30J160; P12.5-30K170; P12.5-30U170; P12.5-50A215; P12.5-50A230; P12.5-50B215; P12.5-50B230; P12.5-50C195; P12.5-50C215; P12.5-50C230; P12.5-50D215; P12.5-50D230; P12.5-50E215; P12.5-50E230; P12.5-50H190; P12.5-50J180; P12.5-50K190; P12.5-50U190; P12.5-50V215; P12.5-50V230; P12.5-50X215; P12.5-50X230; P12.5-80A245; P12.5-80A275; P12.5-80A305; P12.5-80A335; P12.5-80A365; P12.5-80B245; P12.5-80B275; P12.5-80B305; P12.5-80B335; P12.5-80B365; P12.5-80C245; P12.5-80C275; P12.5-80C305; P12.5-80C335; P12.5-80C365; P12.5-80D245; P12.5-80D275; P12.5-80D305; P12.5-80D335; P12.5-80D365; P12.5-80E245; P12.5-80E275; P12.5-80E305; P12.5-80E335; P12.5-80E365; P12.5-80V245; P12.5-80V275; P12.5-80V305; P12.5-80V335; P12.5-80V365; P12.5-80X245; P12.5-80X275; P12.5-80X305; P12.5-80X335; P12.5-80X365; Limb lengthening intramedullary rods 8.5 mm diameter: P8.5-30H170; P8.5-30J160; P8.5-30K170; P8.5-30U170; P8.5-50A215; P8.5-50A230; P8.5-50B215; P8.5-50B230; P8.5-50C195; P8.5-50C215; P8.5-50C230; P8.5-50D215; P8.5-50D230; P8.5-50E215; P8.5-50E230; P8.5-50H190; P8.5-50J180; P8.5-50K190; P8.5-50M165; P8.5-50N150 P8.5-50P165; P8.5-50Q155; P8.5-50U190; P8.5-50V215; P8.5-50V230; P8.5-50X215; P8.5-50X230; P8.5-80A245; P8.5-80A275; P8.5-80A305; P8.5-80A335; P8.5-80A365; P8.5-80B245; P8.5-80B275; P8.5-80B305; P8.5-80B335; P8.5-80B365; P8.5-80C245; P8.5-80C275; P8.5-80C305; P8.5-80C335; P8.5-80C365; P8.5-80D245; P8.5-80D275; P8.5-80D305; P8.5-80D335; P8.5-80D365; P8.5-80E245; P8.5-80E275; P8.5-80E305; P8.5-80E335; P8.5-80E365; P8.5-80V245; P8.5-80V275; P8.5-80V305; P8.5-80V335; P8.5-80V365; P8.5-80X245; P8.5-80X275; P8.5-80X305; P8.5-80X335; P8.5-80X365; Limb lengthening intramedullary rods 10.5 mm diameter: PR10.5-50A215; PR10.5-50A230; PR10.5-50B215; PR10.5-50B230; PR10.5-50C195; PR10.5-50C215; PR10.5-50C230; PR10.5-50D215; PR10.5-50D230; PR10.5-50E215; PR10.5-50E230; PR10.5-80A245; PR10.5-80A275; PR10.5-80A305; PR10.5-80A335; PR10.5-80A365; PR10.5-80B245; PR10.5-80B275; PR10.5-80B305; PR10.5-80B335; PR10.5-80B365; PR10.5-80C245; PR10.5-80C275; PR10.5-80C305; PR10.5-80C335; PR10.5-80C365; PR10.5-80D245; PR10.5-80D275; PR10.5-80D305; PR10.5-80D335; PR10.5-80D365; PR10.5-80E245; PR10.5-80E275; PR10.5-80E305; PR10.5-80E335; PR10.5-80E365; Limb lengthening intramedullary rods 11.5 mm diameter: PR11.5-50A215; PR11.5-50A230; PR11.5-50B215; PR11.5-50B230; PR11.5-50C195; PR11.5-50C215; PR11.5-50C230; PR11.5-50D215; PR11.5-50D230; PR11.5-50E215; PR11.5-50E230; PR11.5-80A245; PR11.5-80A275; PR11.5-80A305; PR11.5-80A335; PR11.5-80A365; PR11.5-80B245; PR11.5-80B275; PR11.5-80B305; PR11.5-80B335; PR11.5-80B365; PR11.5-80C245; PR11.5-80C275; PR11.5-80C305; PR11.5-80C335; PR11.5-80C365; PR11.5-80D245; PR11.5-80D275; PR11.5-80D305; PR11.5-80D335; PR11.5-80D365; PR11.5-80E245; PR11.5-80E275; PR11.5-80E305; PR11.5-80E335; PR11.5-80E365; Limb lengthening intramedullary rods 12.5 mm diameter: PR12.5-50A215; PR12.5-50A230; PR12.5-50B215; PR12.5-50B230; PR12.5-50C195; PR12.5-50C215; PR12.5-50C230; PR12.5-50D215; PR12.5-50D230; PR12.5-50E215; PR12.5-50E230; PR12.5-80A245; PR12.5-80A275; PR12.5-80A305; PR12.5-80A335; PR12.5-80A365; PR12.5-80B245; PR12.5-80B275; PR12.5-80B305; PR12.5-80B335; PR12.5-80B365; PR12.5-80C245; PR12.5-80C275; PR12.5-80C305; PR12.5-80C335; PR12.5-80C365; PR12.5-80D245; PR12.5-80D275; PR12.5-80D305; PR12.5-80D335; PR12.5-80D365; PR12.5-80E245; PR12.5-80E275; PR12.5-80E305; PR12.5-80E335; PR12.5-80E365; Limb lengthening intramedullary rods 9.0 mm diameter: PR9.0-50A215; PR9.0-50A230; PR9.0-50B215; PR9.0-50B230; PR9.0-50C195; PR9.0-50C215; PR9.0-50C230; PR9.0-50D215; PR9.0-50D230; PR9.0-50E215; PR9.0-50E230; PR9.0-80A245; PR9.0-80A275; PR9.0-80A305; PR9.0-80A335; PR9.0-80A365; PR9.0-80B245; PR9.0-80B275; PR9.0-80B305; PR9.0-80B335; PR9.0-80B365; PR9.0-80C245; PR9.0-80C275; PR9.0-80C305; PR9.0-80C335; PR9.0-80C365; PR9.0-80D245; PR9.0-80D275; PR9.0-80D305; PR9.0-80D335; PR9.0-80D365; PR9.0-80E245; PR9.0-80E275; PR9.0-80E305; PR9.0-80E335; PR9.0-80E365; Limb lengthening intramedullary rods 9.5 mm diameter: PR9.5-50A215; PR9.5-50A230; PR9.5-50B215; PR9.5-50B230; PR9.5-50C195; PR9.5-50C215; PR9.5-50C230; PR9.5-50D215; PR9.5-50D230; PR9.5-50E215; PR9.5-50E230; PR9.5-80A245; PR9.5-80A275; PR9.5-80A305; PR9.5-80A335; PR9.5-80A365; PR9.5-80B245; PR9.5-80B275; PR9.5-80B305; PR9.5-80B335; PR9.5-80B365; PR9.5-80C245; PR9.5-80C275; PR9.5-80C305; PR9.5-80C335; PR9.5-80C365; PR9.5-80D245; PR9.5-80D275; PR9.5-80D305; PR9.5-80D335; PR9.5-80D365; PR9.5-80E245; PR9.5-80E275; PR9.5-80E305; PR9.5-80E335; PR9.5-80E365; Trauma intramedullary rods 10.7 mm diameter: T10.7-50A205; T10.7-50A225; T10.7-50A240; T10.7-50B205; T10.7-50B225; T10.7-50B240; T10.7-50C205; T10.7-50C225; T10.7-50C240; T10.7-50D205; T10.7-50D225; T10.7-50D240; T10.7-50E205; T10.7-50E225; T10.7-50E240; T10.7-80A255; T10.7-80A285; T10.7-80A315; T10.7-80A345; T10.7-80A375; T10.7-80B255; T10.7-80B285; T10.7-80B315; T10.7-80B345; T10.7-80B375; T10.7-80C255; T10.7-80C285; T10.7-80C315; T10.7-80C345; T10.7-80C375; T10.7-80D255; T10.7-80D285; T10.7-80D315; T10.7-80D345; T10.7-80D375; T10.7-80E255; T10.7-80E285; T10.7-80E315; T10.7-80E345; T10.7-80E375; Trauma intramedullary rods 12.5 mm diameter: T12.5-50A205; T12.5-50A225; T12.5-50A240; T12.5-50B205; T12.5-50B225; T12.5-50B240; T12.5-50C205; T12.5-50C225; T12.5-50C240; T12.5-50D205; T12.5-50D225; T12.5-50D240; T12.5-50E205; T12.5-50E225; T12.5-50E240; T12.5-80A255; T12.5-80A285; T12.5-80A315; T12.5-80A345; T12.5-80A375; T12.5-80B255; T12.5-80B285; T12.5-80B315; T12.5-80B345; T12.5-80B375; T12.5-80C255; T12.5-80C285; T12.5-80C315; T12.5-80C345; T12.5-80C375; T12.5-80D255; T12.5-80D285; T12.5-80D315; T12.5-80D345; T12.5-80D375; T12.5-80E255; T12.5-80E285; T12.5-80E315; T12.5-80E345; T12.5-80E375; Trauma intramedullary rods 8.5 mm diameter: T8.5-50A205; T8.5-50A225; T8.5-50A240; T8.5-50B205; T8.5-50B225; T8.5-50B240; T8.5-50C205; T8.5-50C225; T8.5-50C240; T8.5-50D205; T8.5-50D225; T8.5-50D240; T8.5-50E205; T8.5-50E225; T8.5-50E240; T8.5-80A255; T8.5-80A285; T8.5-80A315; T8.5-80A345; T8.5-80A375; T8.5-80B255; T8.5-80B285; T8.5-80B315; T8.5-80B345; T8.5-80B375; T8.5-80C255; T8.5-80C285; T8.5-80C315; T8.5-80C345; T8.5-80C375; T8.5-80D255; T8.5-80D285; T8.5-80D315; T8.5-80D345; T8.5-80D375; T8.5-80E255; T8.5-80E285; T8.5-80E315; T8.5-80E345; T8.5-80E375; Locking screws: TSA4.5-020; TSA4.5-025; TSA4.5-030; TSA4.5-035; TSA4.5-040; TSA4.5-045; TSA4.5-050; TSA4.5-055; TSA4.5-060; TSA4.5-065; TSA4.5-070; TSA4.5-075; TSA4-020; TSA4-022.5; TSA4-025; TSA4-027.5; TSA4-030; TSA4-032.5; TSA4-035; TSA4-037.5; TSA4-040; TSA4-042.5; TSA4-045; TSA4-047.5; TSA4-050; TSA4-055; TSA4-060; TSA4-065; TSA4-070; TSA4-075; TSA4-080; TSA4-085; TSA4-090; TSA4-095; TSA4-100; TSA4-100; TSA5-020; TSA5-020; TSA5-022.5; TSA5-022.5; TSA5-025; TSA5-025; TSA5-027.5; TSA5-027.5; TSA5-030; TSA5-030; TSA5-032.5; TSA5-032.5; TSA5-035; TSA5-035; TSA5-037.5; TSA5-037.5; TSA5-040; TSA5-040; TSA5-042.5; TSA5-042.5; TSA5-045; TSA5-045; TSA5-047.5; TSA5-047.5; TSA5-050; TSA5-050; TSA5-052.5; TSA5-055; TSA5-055; TSA5-057.5; TSA5-060; TSA5-060; TSA5-062.5; TSA5-065; TSA5-065; TSA5-067.5; TSA5-070; TSA5-070; TSA5-072.5; TSA5-075; TSA5-075; TSA5-080; TSA5-080; TSA5-085; TSA5-085; TSA5-090; TSA5-090; TSA5-095; TSA5-095; TSA5-100; TSA5-100; TSA5-105; TSA5-105; TSA5-110; TSA5-110; GTIN Numbers: 00812258020002; 00887517001139; 00887517001146; 00887517001153; 00887517001160; 00887517001177; 00887517001184; 00887517001191; 00887517001207; 00887517001214; 00887517001221; 00812258021337; 00812258021344; 00812258021351; 00812258021368; 00812258021375; 00812258021382; 00812258021399; 00812258021405; 00812258021412; 00887517936233; 00887517936240; 00887517936257; 00856719002763; 00856719002770; 00856719002787; 00856719002794; 00856719002800; 00856719002817; 00856719002824; 00856719002831; 00856719002848; 00856719002886; 00856719002893; 00856719002909; 00856719002916; 00856719002923; 00856719002930; 00856719002947; 00856719002954; 00856719002961; 00856719002978; 00856719002985; 00856719002992; 00812258021429; 00812258021436; 00812258021443; 00812258021450; 00812258021467; 00812258021474; 00812258021481; 00812258021498; 00812258021504; 00887517000958; 00887517000965; 00887517000972; 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00812258020781; 00812258020798; 00812258022471; 00812258022488; 00812258022495; 00887517935731; 00887517935748; 00887517935755; 00887517935762; 00887517935779; 00887517935786; 00887517935793; 00887517935809; 00887517935816; 00887517935823; 00812258025359; 00812258025366; 00812258024253; 00812258024260; 00812258024956; 00812258024963; 00812258024970; 00812258024604; 00812258024611; 00812258025700; 00812258025717; 00812258025373; 00812258025380; 00812258025397; 00812258025403; 00812258025410; 00812258024277; 00812258024284; 00812258024291; 00812258024307; 00812258024314; 00812258024987; 00812258024994; 00812258025007; 00812258025014; 00812258025021; 00812258024628; 00812258024635; 00812258024642; 00812258024659; 00812258024666; 00812258025724; 00812258025731; 00812258025748; 00812258025755; 00812258025762; 00812258025427; 00812258025434; 00812258024321; 00812258024338; 00812258025038; 00812258025045; 00812258025052; 00812258024673; 00812258024680; 00812258025779; 00812258025786; 00812258025441; 00812258025458; 00812258025465; 00812258025472; 00812258025489; 00812258024345; 00812258024352; 00812258024369; 00812258024376; 00812258024383; 00812258025069; 00812258025076; 00812258025083; 00812258025090; 00812258025106; 00812258024697; 00812258024703; 00812258024710; 00812258024727; 00812258024734; 00812258025793; 00812258025809; 00812258025816; 00812258025823; 00812258025830; 00812258025632; 00812258025649; 00812258024390; 00812258024406; 00812258025113; 00812258025120; 00812258025137; 00812258024741; 00812258024758; 00812258025984; 00812258025991; 00812258025656; 00812258025663; 00812258025670; 00812258025687; 00812258025694; 00812258024413; 00812258024420; 00812258024437; 00812258024444; 00812258024451; 00812258025144; 00812258025151; 00812258025168; 00812258025175; 00812258025182; 00812258024765; 00812258024772; 00812258024789; 00812258024796; 00812258024802; 00812258026004; 00812258026011; 00812258026028; 00812258026035; 00812258026042; 00812258025496; 00812258025502; 00812258024468; 00812258024475; 00812258025199; 00812258025205; 00812258025212; 00812258024819; 00812258024826; 00812258025847; 00812258025854; 00812258025519; 00812258025526; 00812258025533; 00812258025540; 00812258025557; 00812258024482; 00812258024499; 00812258024505; 00812258024512; 00812258024529; 00812258025229; 00812258025236; 00812258025243; 00812258025250; 00812258025267; 00812258024833; 00812258024840; 00812258024857; 00812258024864; 00812258024871; 00812258025861; 00812258025878; 00812258025885; 00812258025892; 00812258025908; 00812258025564; 00812258025571; 00812258024536; 00812258024543; 00812258025274; 00812258025281; 00812258025298; 00812258024888; 00812258024895; 00812258025915; 00812258025922; 00812258025588; 00812258025595; 00812258025601; 00812258025618; 00812258025625; 00812258024550; 00812258024567; 00812258024574; 00812258024581; 00812258024598; 00812258025304; 00812258025311; 00812258025328; 00812258025335; 00812258025342; 00812258024901; 00812258024918; 00812258024925; 00812258024932; 00812258024949; 00812258025939; 00812258025946; 00812258025953; 00812258025960; 00812258025977; 00812258023836; 00812258023843; 00812258023850; 00812258023119; 00812258023126; 00812258023133; 00812258023591; 00812258023607; 00812258023614; 00812258023355; 00812258023362; 00812258023379; 00812258024079; 00812258024086; 00812258024093; 00812258023867; 00812258023874; 00812258023881; 00812258023898; 00812258023904; 00812258023140; 00812258023157; 00812258023164; 00812258023171; 00812258023188; 00812258023621; 00812258023638; 00812258023645; 00812258023652; 00812258023669; 00812258023386; 00812258023393; 00812258023409; 00812258023416; 00812258023423; 00812258024109; 00812258024116; 00812258024123; 00812258024130; 00812258024147; 00812258023911; 00812258023928; 00812258023935; 00812258023195; 00812258023201; 00812258023218; 00812258023676; 00812258023683; 00812258023690; 00812258023430; 00812258023447; 00812258023454; 00812258024154; 00812258024161; 00812258024178; 00812258023942; 00812258023959; 00812258023966; 00812258023973; 00812258023980; 00812258023225; 00812258023232; 00812258023249; 00812258023256; 00812258023263; 00812258023706; 00812258023713; 00812258023720; 00812258023737; 00812258023744; 00812258023461; 00812258023478; 00812258023485; 00812258023492; 00812258023508; 00812258024185; 00812258024192; 00812258024208; 00812258024215; 00812258024222; 00812258023751; 00812258023768; 00812258023775; 00812258023034; 00812258023041; 00812258023058; 00812258023515; 00812258023522; 00812258023539; 00812258023270; 00812258023287; 00812258023294; 00812258023997; 00812258024000; 00812258024017; 00812258023782; 00812258023799; 00812258023805; 00812258023812; 00812258023829; 00812258023065; 00812258023072; 00812258023089; 00812258023096; 00812258023102; 00812258023546; 00812258023553; 00812258023560; 00812258023577; 00812258023584; 00812258023300; 00812258023317; 00812258023324; 00812258023331; 00812258023348; 00812258024024; 00812258024031; 00812258024048; 00812258024055; 00812258024062; 00887517936011; 00887517936028; 00887517936035; 00887517936042; 00887517936059; 00887517936066; 00887517936073; 00887517936080; 00887517936097; 00887517936202; 00887517936219; 00887517936226; 00887517000033; 00887517000040; 00887517000057; 00887517000064; 00887517000071; 00887517000088; 00887517000095; 00887517000101; 00887517000118; 00887517000125; 00887517000132; 00887517000149; 00887517000156; 00887517000163; 00887517000170; 00887517000187; 00887517000194; 00887517000200; 00887517000217; 00887517000224; 00887517000231; 00887517000248; 00887517000255; 00887517000255; 00812258027728; 00887517000262; 00812258027735; 00887517000279; 00812258027742; 00887517000286; 00812258027759; 00887517000293; 00812258027766; 00887517000309; 00812258027773; 00887517000316; 00812258027780; 00887517000323; 00812258027797; 00887517000330; 00812258027803; 00887517000347; 00812258027810; 00887517000354; 00812258027827; 00887517000361; 00812258027834; 00887517000378; 00812258027841; 00887517000385; 00812258027858; 00812258027865; 00887517000392; 00812258027872; 00812258027889; 00887517000408; 00812258027896; 00812258027902; 00887517000415; 00812258027919; 00812258027926; 00887517000422; 00812258027933; 00812258027940; 00887517000439; 00812258027957; 00887517000446; 00812258027964; 00887517000453; 00812258027971; 00887517000460; 00812258027988; 00887517000477; 00812258027995; 00887517000484; 00812258028008; 00812258028008; 00812258028015; 00812258028015;	10,657 units
Z-1350-2021	NUVASIVE PRECICE UNYTE System (Humerus and Tibia): PRECICE Trauma Nail System/PRECICE Unyte-Humerus Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 165 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 180 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 195 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 210 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 225 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 240 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 255 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 270 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 285 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 300 mm length; End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 0mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 2mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 5mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 10mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 15mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 0mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 2mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 5mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 10mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 15mm); 3.5 mm Locking Screw, 20 mm Length; 3.5 mm Locking Screw 25 mm Length; 3.5 mm Locking Screw 30 mm Length; 3.5 mm Locking Screw 35 mm Length; 3.5 mm Locking Screw 40 mm Length; 3.5 mm Locking Screw 45 mm Length; 3.5 mm Locking Screw 50 mm Length; 3.5 mm Locking Screw 55 mm Length; 3.5 mm Locking Screw 60 mm Length; Locking Screw, 3.5x65mm; Locking Screw, 3.5x70mm; Locking Screw, 3.5x75mm; 5.0 mm Locking Screw 20 mm Length; 5.0 mm Locking Screw 25 mm Length; 5.0 mm Locking Screw 30 mm Length; 5.0 mm Locking Screw 35 mm Length; 5.0 mm Locking Screw 40 mm Length; 5.0 mm Locking Screw 45 mm Length; 5.0 mm Locking Screw 50 mm Length; 5.0 mm Locking Screw 55 mm Length; 5.0 mm Locking Screw 60 mm Length; 5.0 mm Locking Screw 65 mm Length; 5.0 mm Locking Screw 70 mm Length; 5.0 mm Locking Screw 75 mm Length; 5.0 mm Locking Screw 20 mm Length; 5.0 mm Locking Screw 25 mm Length; 5.0 mm Locking Screw 30 mm Length; 5.0 mm Locking Screw 35 mm Length; 5.0 mm Locking Screw 40 mm Length; 5.0 mm Locking Screw 45 mm Length; 5.0 mm Locking Screw 50 mm Length; 5.0 mm Locking Screw 55 mm Length; 5.0 mm Locking Screw 60 mm Length; 5.0 mm Locking Screw 65 mm Length; 5.0 mm Locking Screw 70 mm Length; 5.0 mm Locking Screw 75 mm Length; 5.0 mm X 80 mm Locking Screw, Peg; 5.0 mm X 85 mm Locking Screw, Peg; 5.0 mm X 90 mm Locking Screw, Peg; 5.0 mm X 95 mm Locking Screw, Peg; 5.0 mm X 100 mm Locking Screw, Peg; PRECICE Trauma Nail System/Precice Unyte-Tibia Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 240 mm length; Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 255 mm length; Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 270 mm length; Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 285 mm length; Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 300 mm length; Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 315 mm length; Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 330 mm length; Orthopedic trauma intra; All Lots manufactured between April 2015 to February 2021. PRECICE Unyte Product Codes (for Humerus): Trauma intramedullary rod, humerus, 8.5 mm diameter: CDH8.5-20L165; CDH8.5-20L180; CDH8.5-30L195; CDH8.5-50L210; CDH8.5-50M225; CDH8.5-50M240; CDH8.5-80M255; CDH8.5-80M270; CDH8.5-80M285; CDH8.5-80M300; end cap for trauma intramedullary humeral nail: HEC1-000; HEC2-000; HEC3-000; HEC4-000; HEC5-000; Locking screws: LSB3-020; LSB3-025; LSB3-030; LSB3-035; LSB3-040; LSB3-045; LSB3-050; LSB3-055; LSB3-060; LSB3-065; LSB3-070; LSB3-075; LSB5-020; LSB5-025; LSB5-030; LSB5-035; LSB5-040; LSB5-045; LSB5-050; LSB5-055; LSB5-060; LSB5-065; LSB5-070; LSB5-075; LSC5-020; LSC5-025; LSC5-030; LSC5-035; LSC5-040; LSC5-045; LSC5-050; LSC5-055; LSC5-060; LSC5-065; LSC5-070; LSC5-075; LSC5-080; LSC5-085; LSC5-090; LSC5-095; LSC5-100. GTIN Number (for Humerus): 00812258022730; 00812258022747; 00812258022754; 00812258022761; 00812258022778; 00812258022785; 00812258022792; 00812258022808; 00812258022815; 00812258022822; 00812258028121; 00812258028138; 00812258028145; 00812258028152; 00812258028169; 00812258021337; 00812258021344; 00812258021351; 00812258021368; 00812258021375; 00812258021382; 00812258021399; 00812258021405; 00812258021412; 00887517936233; 00887517936240; 00887517936257; 00856719002886; 00856719002893; 00856719002909; 00856719002916; 00856719002923; 00856719002930; 00856719002947; 00856719002954; 00856719002961; 00856719002978; 00856719002985; 00856719002992; 00812258021511; 00812258021528; 00812258021535; 00812258021542; 00812258021559; 00812258021566; 00812258021573; 00812258021580; 00812258021597; 00812258021603; 00812258021610; 00812258021627; 00887517001030; 00887517001047; 00887517001054; 00887517001061; 00887517001078; Precice Unyte Product Codes (for Tibia): trauma intramedullary rod, 11.5 mm diameter: CDT11.5-30T240; CDT11.5-30T255; CDT11.5-30T270; CDT11.5-30T285; CDT11.5-30T300; CDT11.5-30T315; CDT11.5-30T330; CDT11.5-30T345; CDT11.5-30T360; CDT11.5-30T375; CDT11.5C-30T240; CDT11.5C-30T255; CDT11.5C-30T270; CDT11.5C-30T285; CDT11.5C-30T300; CDT11.5C-30T315; CDT11.5C-30T330; CDT11.5C-30T345; CDT11.5C-30T360; CDT11.5C-30T375; trauma intramedullary rod, 12.5 mm diameter: CDT12.5-30T240; CDT12.5-30T255; CDT12.5-30T270; CDT12.5-30T285; CDT12.5-30T300; CDT12.5-30T315; CDT12.5-30T330; CDT12.5-30T345; CDT12.5-30T360; CDT12.5-30T375; CDT12.5C-30T240; CDT12.5C-30T255; CDT12.5C-30T270; CDT12.5C-30T285; CDT12.5C-30T300; CDT12.5C-30T315; CDT12.5C-30T330; CDT12.5C-30T345; CDT12.5C-30T360; CDT12.5C-30T375; end cap for trauma intramedullary nail: TEC1-000; TEC1-005; TEC1-010; TEC1-015; TEC1-020; Locking screws: TSA4.5-020; TSA4.5-025; TSA4.5-030; TSA4.5-035; TSA4.5-040; TSA4.5-045; TSA4.5-050; TSA4.5-055; TSA4.5-060; TSA4.5-065; TSA4.5-070; TSA4.5-075; TSA4-020; TSA4-022.5; TSA4-025; TSA4-027.5; TSA4-030; TSA4-032.5; TSA4-035; TSA4-037.5; TSA4-040; TSA4-042.5; TSA4-045; TSA4-047.5; TSA4-050; TSA4-055; TSA4-060; TSA4-065; TSA4-070; TSA4-075; TSA4-080; TSA4-085; TSA4-090; TSA4-095; TSA4-100; TSA4-100; TSA5-020; TSA5-020; TSA5-022.5; TSA5-022.5; TSA5-025; TSA5-025; TSA5-027.5; TSA5-027.5; TSA5-030; TSA5-030; TSA5-032.5; TSA5-032.5; TSA5-035; TSA5-035; TSA5-037.5; TSA5-037.5; TSA5-040; TSA5-040; TSA5-042.5; TSA5-042.5; TSA5-045; TSA5-045; TSA5-047.5; TSA5-047.5; TSA5-050; TSA5-050; TSA5-052.5; TSA5-055; TSA5-055; TSA5-057.5; TSA5-060; TSA5-060; TSA5-062.5; TSA5-065; TSA5-065; TSA5-067.5; TSA5-070; TSA5-070; TSA5-072.5; TSA5-075; TSA5-075; TSA5-080; TSA5-080; TSA5-085; TSA5-085; TSA5-090; TSA5-090; TSA5-095; TSA5-095; TSA5-100; TSA5-100; TSA5-105; TSA5-105; TSA5-110; TSA5-110. GTIN Number (for Tibia): 00812258027322; 00812258027339; 00812258027346; 00812258027353; 00812258027360; 00812258027377; 00812258027384; 00812258027391; 00812258027407; 00812258027414; 00812258027421; 00812258027438; 00812258027445; 00812258027452; 00812258027469; 00812258027476; 00812258027483; 00812258027490; 00812258027506; 00812258027513; 00812258027520; 00812258027537; 00812258027544; 00812258027551; 00812258027568; 00812258027575; 00812258027582; 00812258027599; 00812258027605; 00812258027612; 00812258027629; 00812258027636; 00812258027643; 00812258027650; 00812258027667; 00812258027674; 00812258027681; 00812258027698; 00812258027704; 00812258027711; 00812258028039; 00812258028046; 00812258028053; 00812258028060; 00812258028077; 00887517936011; 00887517936028; 00887517936035; 00887517936042; 00887517936059; 00887517936066; 00887517936073; 00887517936080; 00887517936097; 00887517936202; 00887517936219; 00887517936226; 00887517000033; 00887517000040; 00887517000057; 00887517000064; 00887517000071; 00887517000088; 00887517000095; 00887517000101; 00887517000118; 00887517000125; 00887517000132; 00887517000149; 00887517000156; 00887517000163; 00887517000170; 00887517000187; 00887517000194; 00887517000200; 00887517000217; 00887517000224; 00887517000231; 00887517000248; 00887517000255; 00887517000255; 00812258027728; 00887517000262; 00812258027735; 00887517000279; 00812258027742; 00887517000286; 00812258027759; 00887517000293; 00812258027766; 00887517000309; 00812258027773; 00887517000316; 00812258027780; 00887517000323; 00812258027797; 00887517000330; 00812258027803; 00887517000347; 00812258027810; 00887517000354; 00812258027827; 00887517000361; 00812258027834; 00887517000378; 00812258027841; 00887517000385; 00812258027858; 00812258027865; 00887517000392; 00812258027872; 00812258027889; 00887517000408; 00812258027896; 00812258027902; 00887517000415; 00812258027919; 00812258027926; 00887517000422; 00812258027933; 00812258027940; 00887517000439; 00812258027957; 00887517000446; 00812258027964; 00887517000453; 00812258027971; 00887517000460; 00812258027988; 00887517000477; 00812258027995; 00887517000484; 00812258028008; 00812258028008; 00812258028015; 00812258028015; Precice Unyte Product Codes (covers both Humerus and Tibia): trauma intramedullary rod, 10.7 mm diameter: T10.7-50A205; T10.7-50A225; T10.7-50A240; T10.7-50B205; T10.7-50B225; T10.7-50B240; T10.7-50C205; T10.7-50C225; T10.7-50C240; T10.7-50D205; T10.7-50D225; T10.7-50D240; T10.7-50E205; T10.7-50E225; T10.7-50E240; T10.7-80A255; T10.7-80A285; T10.7-80A315; T10.7-80A345; T10.7-80A375; T10.7-80B255; T10.7-80B285; T10.7-80B315; T10.7-80B345; T10.7-80B375; T10.7-80C255; T10.7-80C285; T10.7-80C315; T10.7-80C345; T10.7-80C375; T10.7-80D255; T10.7-80D285; T10.7-80D315; T10.7-80D345; T10.7-80D375; T10.7-80E255; T10.7-80E285; T10.7-80E315; T10.7-80E345; T10.7-80E375; trauma intramedullary rod, 12.5 mm diameter: T12.5-50A205; T12.5-50A225; T12.5-50A240; T12.5-50B205; T12.5-50B225; T12.5-50B240; T12.5-50C205; T12.5-50C225; T12.5-50C240; T12.5-50D205; T12.5-50D225; T12.5-50D240; T12.5-50E205; T12.5-50E225; T12.5-50E240; T12.5-80A255; T12.5-80A285; T12.5-80A315; T12.5-80A345; T12.5-80A375; T12.5-80B255; T12.5-80B285; T12.5-80B315; T12.5-80B345; T12.5-80B375; T12.5-80C255; T12.5-80C285; T12.5-80C315; T12.5-80C345; T12.5-80C375; T12.5-80D255; T12.5-80D285; T12.5-80D315; T12.5-80D345; T12.5-80D375; T12.5-80E255; T12.5-80E285; T12.5-80E315; T12.5-80E345; T12.5-80E375; trauma intramedullary rod, 8.5 mm diameter: T8.5-50A205; T8.5-50A225; T8.5-50A240; T8.5-50B205; T8.5-50B225; T8.5-50B240; T8.5-50C205; T8.5-50C225; T8.5-50C240; T8.5-50D205; T8.5-50D225; T8.5-50D240; T8.5-50E205; T8.5-50E225; T8.5-50E240; T8.5-80A255; T8.5-80A285; T8.5-80A315; T8.5-80A345; T8.5-80A375; T8.5-80B255; T8.5-80B285; T8.5-80B315; T8.5-80B345; T8.5-80B375; T8.5-80C255; T8.5-80C285; T8.5-80C315; T8.5-80C345; T8.5-80C375; T8.5-80D255; T8.5-80D285; T8.5-80D315; T8.5-80D345; T8.5-80D375; T8.5-80E255; T8.5-80E285; T8.5-80E315; T8.5-80E345; T8.5-80E375; GTIN Number (covers both Humerus and Tibia): 00812258023836; 00812258023843; 00812258023850; 00812258023119; 00812258023126; 00812258023133; 00812258023591; 00812258023607; 00812258023614; 00812258023355; 00812258023362; 00812258023379; 00812258024079; 00812258024086; 00812258024093; 00812258023867; 00812258023874; 00812258023881; 00812258023898; 00812258023904; 00812258023140; 00812258023157; 00812258023164; 00812258023171; 00812258023188; 00812258023621; 00812258023638; 00812258023645; 00812258023652; 00812258023669; 00812258023386; 00812258023393; 00812258023409; 00812258023416; 00812258023423; 00812258024109; 00812258024116; 00812258024123; 00812258024130; 00812258024147; 00812258023911; 00812258023928; 00812258023935; 00812258023195; 00812258023201; 00812258023218; 00812258023676; 00812258023683; 00812258023690; 00812258023430; 00812258023447; 00812258023454; 00812258024154; 00812258024161; 00812258024178; 00812258023942; 00812258023959; 00812258023966; 00812258023973; 00812258023980; 00812258023225; 00812258023232; 00812258023249; 00812258023256; 00812258023263; 00812258023706; 00812258023713; 00812258023720; 00812258023737; 00812258023744; 00812258023461; 00812258023478; 00812258023485; 00812258023492; 00812258023508; 00812258024185; 00812258024192; 00812258024208; 00812258024215; 00812258024222; 00812258023751; 00812258023768; 00812258023775; 00812258023034; 00812258023041; 00812258023058; 00812258023515; 00812258023522; 00812258023539; 00812258023270; 00812258023287; 00812258023294; 00812258023997; 00812258024000; 00812258024017; 00812258023782; 00812258023799; 00812258023805; 00812258023812; 00812258023829; 00812258023065; 00812258023072; 00812258023089; 00812258023096; 00812258023102; 00812258023546; 00812258023553; 00812258023560; 00812258023577; 00812258023584; 00812258023300; 00812258023317; 00812258023324; 00812258023331; 00812258023348; 00812258024024; 00812258024031; 00812258024048; 00812258024055; 00812258024062;	229 units
Z-1351-2021	NUVASIVE FREEDOM: End Cap for PRECICE Intramedullary Limb Lengthening System Implant; Packaged End Cap 8.5/10.7mm,¿ +0mm; Packaged End Cap 8.5/10.7mm,¿ +5mm; Packaged End Cap 8.5/10.7mm,¿ +10mm; Packaged End Cap 8.5/10.7mm,¿ +15mm; Packaged End Cap 8.5/10.7mm,¿ +20mm; Packaged End Cap 12.5mm,¿ +0mm; Packaged End Cap 12.5mm,¿ +5mm; Packaged End Cap 12.5mm,¿ +10mm; Packaged End Cap 12.5mm,¿ +15mm; Packaged End Cap 12.5mm,¿ +20mm; 4.0 mm Locking Screw 20 mm Length; 4.0 mm Locking Screw 25 mm Length; 4.0 mm Locking Screw 30 mm Length; 4.0 mm Locking Screw 35 mm Length; 4.0 mm Locking Screw 40 mm Length; 4.0 mm Locking Screw 45 mm Length; 4.0 mm Locking Screw 50 mm Length; 4.0 mm Locking Screw 55 mm Length; 4.0 mm Locking Screw 60 mm Length; 5.0 mm Locking Screw 20 mm Length; 5.0 mm Locking Screw 25 mm Length; 5.0 mm Locking Screw 30 mm Length; 5.0 mm Locking Screw 35 mm Length; 5.0 mm Locking Screw 40 mm Length; 5.0 mm Locking Screw 45 mm Length; 5.0 mm Locking Screw 50 mm Length; 5.0 mm Locking Screw 55 mm Length; 5.0 mm Locking Screw 60 mm Length; 5.0 mm Locking Screw 65 mm Length; 5.0 mm Locking Screw 70 mm Length; 5.0 mm Locking Screw 75 mm Length; 4.0 mm Locking Screw 20 mm Length; 4.0 mm Locking Screw 25 mm Length; 4.0 mm Locking Screw 30 mm Length; 4.0 mm Locking Screw 35 mm Length; 4.0 mm Locking Screw 40 mm Length; 4.0 mm Locking Screw 45 mm Length; 4.0 mm Locking Screw 50 mm Length; 4.0 mm Locking Screw 55 mm Length; 4.0 mm Locking Screw 60 mm Length; 4.0 mm X 65 mm Locking Screw, Peg; 4.0 mm X 70 mm Locking Screw, Peg; 4.0 mm X 75 mm Locking Screw, Peg; 4.0 mm X 80 mm Locking Screw, Peg; 4.0 mm X 85 mm Locking Screw, Peg; 4.0 mm X 90 mm Locking Screw, Peg; 4.0 mm X 95 mm Locking Screw, Peg; 4.0 mm X 100 mm Locking Screw, Peg; 5.0 mm Locking Screw 20 mm Length; 5.0 mm Locking Screw 25 mm Length; 5.0 mm Locking Screw 30 mm Length; 5.0 mm Locking Screw 35 mm Length; 5.0 mm Locking Screw 40 mm Length; 5.0 mm Locking Screw 45 mm Length; 5.0 mm Locking Screw 50 mm Length; 5.0 mm Locking Screw 55 mm Length; 5.0 mm Locking Screw 60 mm Length; 5.0 mm Locking Screw 65 mm Length; 5.0 mm Locking Screw 70 mm Length; 5.0 mm Locking Screw 75 mm Length; 5.0 mm X 80 mm Locking Screw, Peg; 5.0 mm X 85 mm Locking Screw, Peg; 5.0 mm X 90 mm Locking Screw, Peg; 5.0 mm X 95 mm Locking Screw, Peg; 5.0 mm X 100 mm Locking Screw, Peg; Orthopedic intramedullary limb lengthening rod, residual limb lengthener, 14 mm diameter, 130 mm length; Orthopedic surgical instrument - for use with the intramedullary limb lengthening rod, residual limb lengthener;; All Lots manufactured between April 2015 to February 2021. NUVASIVE Freedom Product Codes: End Caps: CPA1-000; CPA2-000; CPA2-005; CPA2-010; CPA2-015; CPA2-020; CPA3-000; CPA3-005; CPA3-010; CPA3-015; CPA3-020; Locking screws: LSB4-020; LSB4-025; LSB4-030; LSB4-035; LSB4-040; LSB4-045; LSB4-050; LSB4-055; LSB4-060; LSB5-020; LSB5-025; LSB5-030; LSB5-035; LSB5-040; LSB5-045; LSB5-050; LSB5-055; LSB5-060; LSB5-065; LSB5-070; LSB5-075; LSC4-020; LSC4-025; LSC4-030; LSC4-035; LSC4-040; LSC4-045; LSC4-050; LSC4-055; LSC4-060; LSC4-065; LSC4-070; LSC4-075; LSC4-080; LSC4-085; LSC4-090; LSC4-095; LSC4-100; LSC5-020; LSC5-025; LSC5-030; LSC5-035; LSC5-040; LSC5-045; LSC5-050; LSC5-055; LSC5-060; LSC5-065; LSC5-070; LSC5-075; LSC5-080; LSC5-085; LSC5-090; LSC5-095; LSC5-100; Limb lengthening intramedullary rod, residual limb lengthener: R14-100A130; Orthopedic surgical instrument - for use with the intramedullary limb lengthening rod, residual limb lengthener: RLL1-000; GTIN Numbers: 00812258020002; 00887517001139; 00887517001146; 00887517001153; 00887517001160; 00887517001177; 00887517001184; 00887517001191; 00887517001207; 00887517001214; 00887517001221; 00856719002763; 00856719002770; 00856719002787; 00856719002794; 00856719002800; 00856719002817; 00856719002824; 00856719002831; 00856719002848; 00856719002886; 00856719002893; 00856719002909; 00856719002916; 00856719002923; 00856719002930; 00856719002947; 00856719002954; 00856719002961; 00856719002978; 00856719002985; 00856719002992; 00812258021429; 00812258021436; 00812258021443; 00812258021450; 00812258021467; 00812258021474; 00812258021481; 00812258021498; 00812258021504; 00887517000958; 00887517000965; 00887517000972; 00887517000989; 00887517000996; 00887517001009; 00887517001016; 00887517001023; 00812258021511; 00812258021528; 00812258021535; 00812258021542; 00812258021559; 00812258021566; 00812258021573; 00812258021580; 00812258021597; 00812258021603; 00812258021610; 00812258021627; 00887517001030; 00887517001047; 00887517001054; 00887517001061; 00887517001078; 00812258024239; 00812258026479;	59 units

Based on the official FDA remedy

What to do — step by step

Check Product Codes
Look for the specific product codes listed in the recall, such as CDH8.5-20L165 for humerus rods or CDT11.5-30T240 for tibia rods.
Contact Manufacturer
Reach out to NuVasive Specialized Orthopedics, Inc. for further guidance on the recall and potential remedies.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution, including U.S. Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 2 months after the firm started it.

Feb 12, 2021Firm started the recall
Apr 5, 2021FDA classified it Class II
Apr 14, 2021Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/63273-nuvasive-precice-unyte-system-not-approved-for-children-under-18">NuVasive PRECICE Unyte System: Not Approved for Children Under 18 (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1350-2021 (February 12, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1350-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.