Stop using nowMedical device recall · FDA · Published December 23, 2020
Biomet Clavicle Plate Recall: Cold Welding Risk During Surgery
Biomet recalls clavicle plating system item 233500004 due to cold welding risk during surgery. This may cause drill fracture. Affected units have specific lot numbers.
The instruments may become cold welded together when the drill is inserted through the Soft Tissue Guide. This prevents disassociation of the instruments and potentially leads to an increased chance of fracture of the drill.
Take action
Contact the company
📍Recalling firmBiomet, Inc.56 E Bell Dr · Warsaw, IN 46582-6989
“Biomet Clavicle Plate Recall: Cold Welding Risk During Surgery.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63603-biomet-clavicle-plate-recall-cold-welding-risk-during-surgery. Based on FDA recall #Z-0882-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0882-2021%22&limit=1).
The FDA announced on Dec. 23, 2020, that Biomet, Inc. is recalling the A.L.P.S. Clavicle Plating System due to a Class II hazard. The instruments may become cold welded together, preventing disassociation and potentially leading to drill fracture.
How to tell if you have it
Brand: Biomet
Product: A.L.P.S. Clavicle Plating System, Plate, Fixation, Bone
Item Number: 233500004
UPC: 00880304834644
Lot codes: 516349, 545167
Distribution: Nationwide
The hazard
According to the FDA, the instruments may become cold welded together when the drill is inserted through the Soft Tissue Guide. This prevents disassociation of the instruments and potentially leads to an increased chance of fracture of the drill.
Context
GovInfoNow's records show Biomet, Inc. has 28 other recalls on record since Feb. 28, 2018. Other recent recalls include the Biomet Intramedullary Bone Saw Blade Recall (July 1, 2026), the Biomet ZipT recall (Sept. 23, 2025), and the Biomet Juggerknot Mini Soft Anchors Recall (Sept. 9, 2025). Other recent recalls of similar products include the Orthalign Drill Plate Recall (Feb. 10, 2026) and the Olympus PK Cutting Forceps Recall (Feb. 25, 2026).
How to tell if you have this one
Check for item number 233500004 on the clavicle plating system. Affected units have lot numbers 516349 or 545167. This product is used for clavicle fracture fixation.
Brand
Biomet
Product
A.L.P.S. Clavicle Plating System, Plate, Fixation, Bone, Item Number 233500004
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Stop Using Immediately
Discard the clavicle plating system if it has lot numbers 516349 or 545167.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.3 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-0882-2021 (December 23, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0882-2021 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.