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.
Biomet is recalling a clavicle plating system used in bone fixation. The instruments can cold weld together during surgery, potentially causing drill fractures. This is a serious surgical risk that requires immediate attention.
The instruments may cold weld together when the drill passes through the soft tissue guide. This prevents separation and increases the chance of drill fracture during surgery. The risk occurs during normal surgical use.
Surgical teams using the clavicle plating system for bone fixation are affected. Patients undergoing clavicle fracture repairs with this specific item are at highest risk.
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.
Discard the clavicle plating system if it has lot numbers 516349 or 545167.
The item number is 233500004.
Lot numbers 516349 and 545167 are affected.
The recall does not mention any fix; affected units must be discarded.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0882-2021 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-0882-2021 from Biomet. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
