Biomet recalls certain shoulder stem implants due to potential poor adhesion from unvalidated 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 shoulder implants that may have poor adhesion after waterjet rework. This could lead to the implant loosening or failing after surgery, causing pain or needing additional procedures.
The shoulder stem implants may not stick properly to the bone after surgery because they were reworked using an unvalidated waterjet process. This could cause the implant to loosen or fail over time, leading to pain or needing extra surgery.
Patients who received the specific shoulder stem implant (item number 113618) during surgery between 2020 and 2022 are most at risk. Others are unlikely to be affected.
Check for the item number 113618 on the implant packaging. The lot number 732370 or UDI code (01)00880304554191(17)290802(10)732370 indicates the affected items.
Look for the item number 113618, lot number 732370, or UDI code (01)00880304554191(17)290802(10)732370 on the implant packaging.
The recall does not require stopping use; it's for patients who received the implant during surgery. Contact your surgeon for advice.
Check for the item number 113618, lot number 732370, or UDI code (01)00880304554191(17)290802(10)732370 on the implant packaging.
The recall does not provide a fix; it's for patients who received the implant during surgery to monitor for complications.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0673-2022 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-0673-2022 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.
