Lower risk Medical device recall · FDA · Published November 25, 2020

Biomet 3.0mm Cannulated Screw System Recall: Risk of Contaminated Devices

Biomet recalls specific lots of 3.0mm cannulated screw systems due to potential packaging seal breaches that could compromise sterility. Affected items may not be safe for medical use.

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

🇺🇸 FDA recall #Z-0616-2021Medical device Biomet ›

Lower-risk recall

Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

Take action

Contact the company

Recalling firmBiomet, Inc.56 E Bell Dr · Warsaw, IN 46582-6989

✎ GovInfoNow plain-language explainer

Biomet is recalling specific lots of 3.0mm cannulated screw systems because the packaging might have been compromised, risking contamination. This could lead to infections or other complications during surgery. Read more at govinfonow.com/recall/63761-biomet-3-0mm-cannulated-screw-system-recall-risk-of-contaminated.

Source Summary by GovInfoNow · govinfonow.com/recall/63761-biomet-3-0mm-cannulated-screw-system-recall-risk-of-contaminated · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0616-2021

Cite this page

“Biomet 3.0mm Cannulated Screw System Recall: Risk of Contaminated Devices.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63761-biomet-3-0mm-cannulated-screw-system-recall-risk-of-contaminated. Based on FDA recall #Z-0616-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0616-2021%22&limit=1).

The FDA announced on November 25, 2020, that Biomet, Inc. is recalling specific lots of sterile medical devices due to potential breaches in the sterile seal. The agency issued recall number Z-0616-2021 for the affected products.

How to tell if you have it

Brand: Biomet
Product names: 3.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm)
Item numbers: 110009787, 110009790, 110009794, 110009796, 110009798, 110009800
Lot codes: 180140, 180150, 180160, 371180, 371190, 371250

The hazard

According to the FDA, specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

Context

GovInfoNow's records show Biomet, Inc. has 28 other recalls on record since February 28, 2018. Other recent recalls of similar products include the Biomet Intramedullary Bone Saw Blade Recall (July 1, 2026) and the Biomet ZipT recall (September 23, 2025). Other recent recalls of similar products include the Medtronic GUNDRY Cannula Recall (April 21, 2026), the Medtronic Bio-Medicus Adult Cannula Kit Recall (May 25, 2026), and the Medtronic DLP Retrograde Cannula Recall (April 21, 2026).

How to tell if you have this one

Check for item numbers 110009787, 110009790, 110009794, 110009796, 110009798, or 110009800. The affected lots are 180140, 180150, 180160, 371180, 371190, or 371250.

Brand
Biomet
Category
Medical device

FDA recall event · 16 products

All 16 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
Terminated
Distribution
Worldwide distribution. US nationwide, ARGENTINA, AUSTRALIA, Brazil, CANADA, CHILE, CHINA, COSTA RICA, EMEA, HONG KONG, INDIA, JAPAN, KOREA, MALAYSIA, NEW ZEALAND, SINGAPORE, and TAIWAN

Recall number	Product, codes & lots	Quantity
Z-0616-2021	3.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009787 110009790, 110009794, 110009796, 110009798, 110009800 - Product Usage: Fracture fixationof small bones, small bone fragements and long bones.; Lots 180140 180150 180160 371180 371190 371250	7,428 units
Z-0617-2021	4.0/5.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009810, 110009821, 110009825, 110009852 - Product Usage: Fracture fixationof small bones, small bone fragements and long bones.; Lots 180720 334220 285750 285760	N/A
Z-0618-2021	6.5/8.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009929, 110009934, 110009935, 110009936, 110009993, 110009994, 110009996, 110009998, 110010000, 110010003, 110010029, 110010030, 110010032, 110010099 - Product Usage: Fracture fixationof small bones, small bone fragements and long bones.; Lots 167600 288790 286450 368030 180660 285790 285800 179940 179960 179980 180020 288880 288890 288750 179750	7428
Z-0619-2021	Comprehensive Reverse Shoulder System, Item numbers 115394, 115395, 115396, 115398, 180550, 180551, 180552, 180553, 180554, 180555, 180556, 180557, 180558, 180559, 180560, 180562 - Product Usage: indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthroplasty and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff The patient must anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.; Lots 208000 270240 270260 208010 214760 270290 270300 270310 484060 484150 208130 155060 208270 472020 193140 193200 193220 193300 272150 272290 354260 354350 497880 497910 497930 497970 498680 498690 498700 509140 214470 214490 214500 214520 154290 154300 154360 272530 498790 498800 498860 498870 154420 154430 214610 272620 272680 354050 354090 354110 354120 354130 354150 498880 498890 498910 498920 498940 498960 214630 214640 214650 272730 376710 625850 214660 353570 272770 272840 353600 499060 625860 625870 625880 625900 214700 351300 352990 353620 353650 214710 214720 214730 353230 353240 353270 353280 353300 214740 272920 353310 353340 353350 214750 353370	7428
Z-0620-2021	Comprehensive Total Shoulder System/Bio-Modular Choice Shoulder System, Item number 406669 - Product Usage: Surgical instrument handle, non-torque-limiting.; Lot numbers 253970 279180 417710 499280	7428
Z-0621-2021	Custom Cancellous Thread, Item numbers CP161941, CP161943 - Product Usage: 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. 5. Revision of previously failed total hip arthroplasty.; Lot numbers 534760 534800 427670	7428
Z-0622-2021	M/H MODULAR STEM, Item number 13-104756 - Product Usage: intended for use in limb salvage procedures.; Lot number 832990	7428
Z-0623-2021	OSS Polyethylene Tibial Bushing, Item number 150476 - Product Usage: intended for use in limb salvage.; Lots 059680 542010 542020	7428
Z-0624-2021	Oxford Fixed Lateral, Item numbers 154330, 154370, 154373 154376 - Product Usage: indicated for use in the lateral compartment and intended to be implanted with bone cement.; Lots 197660 207230 085200 155720	7428
Z-0625-2021	PHOENIX, Interlocking screw for IM nail, Item numbers 14-405040, 14-405042, 14-405044, 14-405070 - Product Usage: Fracture fixation of small bones, small bone fragements and long bones.; Lot numbers 373200 168810 450100 168540 450090	7428
Z-0626-2021	RapidFire Clip, Item Number 95-0154 - Product Usage: Fixation of Craniofacial bone.; Lots 080580 231760 359160 359170 381910 382870 382900 382970 383010	7428
Z-0627-2021	RINGLOC ACETABULAR SYSTEM Self-tapping bone screws, Item numbers 103531, 103533, 103534, 103535 - Product Usage: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented; Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component); Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer.; Lots 259830 259860 259880 259890 259910 259920 260020 260140 260160	7428
Z-0628-2021	RINGLOC BIPOLAR Hip System Bi Polar Locking Ring, Item number 11-165304 - Product Usage: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate, Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented, Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented.; Lot 173500	7428
Z-0629-2021	Sterile Trac System Thinflap 24 MM Burr Hole Plate, Item number SP-STA-1021-12 - Product Usage: Fixation of Cranial bone; Lot 078390	7428
Z-0630-2021	Titanium IFS, Item number 909680 - Product Usage: Bone to bone fixation.; Lot 750930	7428
Z-0631-2021	RingLoc+ Quick Connect Drill Bit, Item numbers 31-323215, 31-323220, 31-323230, 31-323240 - Product Usage: Bit, Drill.; Lots 492670 562350 253280 253290 253300 278210 278230 417030 608110 608150 677300 253320 267910 267920 267930 267940 267960 267970 278160 363700 363720 363740 386960 492750 507930 507940 507980 508000 232590 232610 386830 386850 386860 386870 492720 530950 386840	7428

Based on the official FDA remedy

What to do — step by step

Check Item Numbers
Verify if your screws have item numbers 110009787, 110009790, 110009794, 110009796, 110009798, or 110009800.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution. US nationwide, ARGENTINA, AUSTRALIA, Brazil, CANADA, CHILE, CHINA, COSTA RICA, EMEA, HONG KONG, INDIA, JAPAN, KOREA, MALAYSIA, NEW ZEALAND, SINGAPORE, and TAIWAN” 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 terminated this recall 3.4 years after the firm started it.

Nov 25, 2020Firm started the recall
Dec 17, 2020FDA classified it Class II
Dec 23, 2020Published in FDA’s Enforcement Report
May 8, 2024FDA terminated the recall

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/63761-biomet-3-0mm-cannulated-screw-system-recall-risk-of-contaminated">Biomet 3.0mm Cannulated Screw System Recall: Risk of Contaminated Devices (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-0616-2021 (November 25, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0616-2021 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.