Biomet recalls certain shoulder implants due to potential poor adhesion from incorrect rework. Affected items may not bond properly to bone, risking failure. Contact Biomet for details.
The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were porous plasma coated or recoated at a vendor that were then reworked through the internal waterjet rework process. The waterjet rework process for porous plasma coating is not validated for products that were coated at a vendor.
Biomet is recalling a specific shoulder implant model because it may not adhere properly to bone due to a manufacturing error. This could lead to implant failure and require additional surgery.
The implant coating was reworked using an unvalidated waterjet process, which may cause the coating to not stick well to the implant. This could lead to the implant failing to bond with bone over time.
Orthopedic surgeons and patients who received the recalled implant model are affected. Patients with the specific implant size and lot number are most at risk.
Check for the item number 113632, lot number 327160, and UDI code (01)00880304449749(17)290819(10)327160 on the implant packaging or label.
Look for the item number 113632, lot number 327160, and UDI code (01)00880304449749(17)290819(10)327160 on the implant packaging or label.
The implant coating was reworked using an unvalidated waterjet process, which may cause the coating to not stick well to the implant.
Check the implant details to see if it matches the recalled model. If it does, contact Biomet for further instructions.
The recall record does not specify a remedy or fix for this issue.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0675-2022 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-0675-2022 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.
