Biomet recalls certain shoulder stem implants due to potential poor adhesion from improper waterjet rework. Affected items may not stay securely attached, risking complications after surgery.
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 specific shoulder stem implants that may have poor adhesion due to an incorrect rework process. This could lead to the implant loosening or failing after surgery, which is serious for patients who have had the procedure.
The shoulder stems were reworked using a waterjet process that wasn't validated for porous plasma coatings. This could cause the coating to not stick properly to the implant, potentially leading to loosening or failure after surgery.
Patients who received the recalled shoulder stem implants during surgery are most at risk. The recall applies to individuals who had the implant placed using the specific model and lot numbers listed in the recall notice.
Check for the item number 113611 and lot number 821170 on the implant. The recall covers all implants with this specific model that were reworked through the internal waterjet process.
Look for the item number 113611 and lot number 821170 on the implant to confirm if it's affected.
The recall occurs because the shoulder stems may have insufficient adhesion strength due to an incorrect rework process involving waterjet technology for porous plasma coatings.
No, the recall does not require immediate removal. Patients should check if their implant matches the affected model and lot numbers and contact Biomet for further guidance.
Contact Biomet directly to confirm if your implant is affected and follow their instructions for next steps.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0671-2022 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-0671-2022 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.
