Biomet recalls shoulder implants with potentially weak plasma coating that may detach. Affected items have specific model and lot numbers. Contact for return or repair options.
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 type of shoulder implant due to potential coating issues that could lead to detachment. This affects patients who received the implant with the described model and lot numbers.
The implant's porous plasma coating may not have proper adhesion strength after rework. This could cause the coating to detach from the implant, potentially leading to complications during surgery or after implantation.
Patients who received the specific shoulder implant model with lot number 439470 are most at risk. The recall applies to those who had the implant installed using the recalled product.
Check for the model name 'Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 14 MM, 55 MM Long' and lot number 439470 on the implant. The item number is 113614.
Reach out to Biomet directly to confirm if your implant is affected and get instructions for next steps.
The recall indicates potential coating adhesion issues, but the risk of serious injury is not described in the official notice.
Look for the model name and lot number 439470 on the implant. The item number is 113614.
Contact Biomet directly to determine if your implant is affected and get 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-0672-2022 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-0672-2022 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.
