Synthes (USA) Products LLC recalls
Every recall we track for Synthes (USA) Products LLC — 74 in all, from 2017–2026 — plus the complaints and injury reports the public filed about them. 3 are rated “stop using now”.
Recalls per year, by danger level
Recalls from Synthes (USA) Products LLC fell by more than half in 2025 (2, down from 10 in 2024). 4% rated “stop using now”.
All FDA recall records for Synthes (USA) Products LLC since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 1 | 0 | 7 | 0 | 8 |
| 2018 | 0 | 0 | 7 | 0 | 7 |
| 2019 | 0 | 0 | 2 | 0 | 2 |
| 2020 | 0 | 17 | 2 | 14 | 33 |
| 2021 | 0 | 1 | 0 | 0 | 1 |
| 2022 | 0 | 4 | 2 | 0 | 6 |
| 2023 | 0 | 0 | 3 | 0 | 3 |
| 2024 | 2 | 1 | 7 | 0 | 10 |
| 2025 | 0 | 0 | 2 | 0 | 2 |
| 2026 (to date) | 0 | 0 | 2 | 0 | 2 |
Most common reasons for Synthes (USA) Products LLC recalls
What to do if you have a recalled Synthes (USA) Products LLC product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Synthes (USA) Products LLC recalls
20 shown- Lower riskMedical device
Synthes (USA) Products LLC recalls 2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US.
Synthes recalls 2.4V Tap Locking Screw Taps with incorrect threads that may cause improper fitting. Affected lots 68900P9 and 68982P8 need replacement to prevent damage.
SynthesFeb 25, 2026 - Lower riskMedical device
Synthes (USA) Products LLC recalls LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 04.045.346TS. Used in RFN-ADVANCEDTM
Synthes recalls LOW PROF LCKNG SCREW (Product Code 04.045.346TS) due to incorrect length labeling on packaging. 42mm screws labeled as 46mm and vice versa. No immediate action needed as this is a labeling error, not a safety hazard.
SynthesSep 26, 2025 - Lower riskMedical device
Synthes (USA) Products LLC recalls STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for tightening, loosening, or removing of screw implants
Synthes recalls Stardrive screwdrivers without a 5-degree relief cut that may not engage with 1.3mm/1.5mm screws, causing surgical delays. Affected units include specific lot numbers for orthopedic surgery tools.
SynthesApr 25, 2024 - Lower riskMedical device
Synthes (USA) Products LLC recalls Opal, Intervertebral Cage, 10x32mm, h 11mm, Revolvable-Indicated for degenerative spine disease Part Number: 08.803.231S
Synthes recalls unsterilized Opal spinal implants (part 08.803.231S) due to sterility risks. Affected units may cause infection or complications if used without proper sterilization.
SynthesJan 24, 2024 - Lower riskMedical device
Synthes (USA) Products LLC recalls TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intended for temporary fixation and stabilization of
Synthes recalls TFN-Advanced Femoral Nails with incorrect length labels that could lead to improper surgical fixation. Affected units were sold between 2020-2022.
SynthesFeb 1, 2023 - Use cautionMedical device
Synthes (USA) Products LLC recalls SPEED 9X10X10mm Continuous Compression Implant, Product No. SE-0910
Synthes recalls SPEED 9X10X10mm Continuous Compression Implant (Product No. SE-0910) due to incorrect drill guide causing potential bone damage during surgery. Affected units sold with specific lot numbers.
SynthesSep 27, 2022 - Use cautionMedical device
Synthes (USA) Products LLC recalls Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001
Synthes recalls Hammertoe CCI Kit (part 46.239.001) due to drill pin incompatibility with template causing surgical delays or soft tissue damage. Affected units sold with lot numbers MHC220119/MHC220120.
SynthesAug 30, 2022 - Lower riskMedical device
Synthes (USA) Products LLC recalls Radial Head Replacement System Implant is a one-piece, stemmed radial head replacement. The radial head is available in
Synthes recalls radial head replacement implants due to infection and sepsis risks. All models with specific serial numbers are affected.
SynthesApr 7, 2022 - Use cautionMedical device
Synthes (USA) Products LLC recalls Universal Chuck-The Universal Chuck is an Instrument Handle provided as an alternative instrument available for use in
Synthes recalls Universal Chuck instrument handles used in orthopedic surgery due to risk of top cap detaching if jammed, causing surgical delays or infection.
SynthesDec 22, 2021 - Use cautionMedical device
Synthes (USA) Products LLC recalls DePuy Synthes 12.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.020S
DePuy Synthes recalls 12.0MM reamer heads for RIA 2 surgical use due to breakage risk when improper techniques are applied, potentially causing tissue damage.
DePuy SynthesNov 19, 2020 - UnratedMedical device
Synthes (USA) Products LLC recalls END RING 17MM X 22MM LATERAL OR ANTERIOR/5 DEG (TI) Product Number: 495.394 - Product Usage: is a vertebral body
Synthes recalls END RING 17mm x 22mm spinal implants due to incorrect labeling as a general medical device instead of specially controlled medical device. Affected units have specific product numbers and lot numbers.
SynthesSep 21, 2020 - Lower riskMedical device
Synthes (USA) Products LLC recalls DePuy Synthes Trauma LCP One-Third Tubular Plate with Collar 8 Holes / 93mm - Product Usage: intended for fixation of
Synthes recalls LCP One-Third Tubular Plates with potential reduced screw locking strength due to dimensional tolerance issues. Affected plates may not hold securely in fractures.
SynthesJul 21, 2020 - Lower riskMedical device
Synthes (USA) Products LLC recalls Synapse System 3.5mm TI Cancellous Polyaxial Screws, Part No. 04.615.026 for use in spinal surgery
Synthes recalls 3.5mm spinal screws that measure 4.0mm instead of 3.5mm. This size error could cause improper spinal fusion. Affected products include Part No. 04.615.026 sold under 10L2702.
SynthesSep 16, 2019 - Lower riskMedical device
Synthes (USA) Products LLC recalls MODIFIED INSTRUMENTS: Trial Spacer 7mm with T-Handle Trial Spacer 8mm with T-Handle Trial Spacer 9mm with T-Handle
Synthes recalls trial spacers with T-handle that were modified outside approved manufacturing. These devices may not function as intended due to improper production.
SynthesSep 5, 2019 - Lower riskMedical device
Synthes (USA) Products LLC recalls 3.0mm Headless Compression Screw, Long Thread 18mm, Part Number 04.226.118 DePuy Synthes 3.0mm Headless Compression
Synthes recalls 3.0mm headless compression screws with incorrect thread length (4mm instead of 6mm) that may not fit properly in medical implants.
SynthesSep 12, 2018 - Lower riskMedical device
Synthes (USA) Products LLC recalls Synthes Torque Limiting Handle, Part Number 03.231.013 This device is used in systems indicated for fracture fixation.
Synthes recalls torque limiting handles with part number 03.231.013 due to potential rust from high-carbon ball bearings, which may affect fracture fixation systems.
SynthesMay 4, 2018 - Lower riskMedical device
Synthes (USA) Products LLC recalls Retractor f/Sciatic Nerve; Part number: 03.100.013; UDI: 10886982070623
Synthes recalls sciatic nerve retractors with part number 03.100.013 due to potential microspores forming in the handle that could allow fluid to enter. Affected units include specific lot numbers.
SynthesApr 2, 2018 - Lower riskMedical device
Synthes (USA) Products LLC recalls Part no. 690.379, Graphic Case F/6.5mm Cannulated Screw Set
Synthes recalls 690.379 Graphic Case F/6.5mm Cannulated Screw Set due to screws measuring 5. 41mm shorter than actual length. This could lead to improper surgical fixation. Affected units sold in the US.
SynthesMar 5, 2018 - Lower riskMedical device
Synthes (USA) Products LLC recalls 2.5 mm Reaming Rod, Ball tip, 950 mm, sterile, Part Number: 351.706S Reaming Rods are intended for guiding of reamers
Synthes recalls 2.5mm reaming rods with potential sterility issues due to packaging seal gaps. These surgical tools were distributed from March 21 to June 23, 2017. Check product lot numbers for affected items.
SynthesJul 26, 2017 - Stop using nowMedical device
Synthes (USA) Products LLC recalls 11MM/130 Degree Titanium Trochanteric Fixation Nail 380MM/Right, Sterile
Synthes recalls sterile titanium trochanteric fixation nails with missing locking mechanisms. Affected lot H302839 expires Jan 2026. Stop using immediately to prevent injury.
SynthesJul 21, 2017
Synthes (USA) Products LLC recall questions
How many recalls has Synthes (USA) Products LLC had?
74 recalls from Synthes (USA) Products LLC are on record with U.S. safety agencies, from 2017–2026.
What is the most recent Synthes (USA) Products LLC recall?
Synthes (USA) Products LLC recalls 2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US., dated Feb 25, 2026. Every Synthes (USA) Products LLC recall is listed on this page, newest first.
Why are Synthes (USA) Products LLC products recalled?
The most common reasons on record: Products not sterilized, sterility cannot be confirmed (9).
What should I do if I have a recalled Synthes (USA) Products LLC product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Synthes (USA) Products LLC recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.