Biomet recalls certain Comprehensive Shoulder System Mini Humeral Stems due to potential coating adhesion issues from improper rework. Affected items may have insufficient strength, requiring immediate action.
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 implants that may have weak coating adhesion from improper rework. This could lead to implant failure during use, so affected users should contact Biomet for guidance.
The porous plasma coating on these implants may not adhere properly due to an incorrect rework process. This could cause the implant to fail during use, potentially leading to complications like infection or implant dislocation.
Patients who received the recalled shoulder implant model (Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 11 MM, 83 MM Long) are affected. Surgeons and medical staff who used the product during implantation are at higher risk.
Check for the item number 113631 and lot number 821860 on the implant. The recall covers all implants with porous plasma coating that were reworked through the internal waterjet process.
Reach out to Biomet directly for guidance on whether your implant is affected and what steps to take next.
No, this recall specifically applies to the Comprehensive Shoulder System Mini Humeral Stem with porous plasma coating and item number 113631.
Check for the item number 113631 and lot number 821860 on your implant. The recall covers implants reworked through the internal waterjet process.
Contact Biomet directly for guidance on whether your implant is affected and what steps to take next.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0674-2022 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-0674-2022 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
