Biomet recalls certain shoulder implants due to potential coating adhesion issues from improper rework. Affected items may have reduced strength and require replacement.
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 due to an incorrect rework process. This could lead to implant failure if the coating doesn't stick properly.
The implants were reworked using an unvalidated waterjet process for porous plasma coating. This could result in the coating not adhering properly to the implant, potentially causing failure.
Orthopedic surgeons and patients who received the recalled shoulder implants. Those with the specific model and lot numbers are most at risk.
Check for the item number 113635, lot number 396250, and UDI code (01)00880304462663(17)281121(10)396250 on the implant packaging or label.
Look for the item number 113635, lot number 396250, and UDI code (01)00880304462663(17)281121(10)396250 on the implant packaging or label.
The recalled implant is the Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 15 MM, 83 MM Long with item number 113635.
The products underwent an incorrect rework operation for the porous plasma coating, which may result in insufficient adhesion strength.
The recall does not specify a stop-use instruction; the remedy is null, so users should check if they have the affected model and lot numbers.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0677-2022 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-0677-2022 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.
