Biomet recalls certain shoulder implants due to potential adhesion issues from improper coating rework. Affected items may not hold securely, risking dislocation. 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 stick properly to the bone during surgery. This could lead to the implant moving or failing after implantation.
The implant's coating was reworked using an unvalidated waterjet process, which may cause the coating to not adhere properly to the bone. This could lead to the implant shifting or failing after surgery.
Orthopedic surgeons and patients who received the recalled shoulder implant during surgery are affected. Patients with the implant are at risk of dislocation or failure.
Check for the item number 113633 and lot number 994800 on the implant. The recall covers implants that were coated or recoated at a vendor and then reworked through the internal waterjet process.
Reach out to Biomet directly for specific guidance on the recalled implant model and lot numbers.
The recall indicates potential adhesion issues from improper rework, but the implant may be safe if used correctly. Biomet has not confirmed if the implant is dangerous in normal use.
Look for item number 113633 and lot number 994800 on the implant. The recall covers implants that were coated or recoated at a vendor and then reworked through the internal waterjet process.
The recall does not require immediate removal; contact Biomet for specific guidance on the affected implant.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0676-2022 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-0676-2022 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.
