Biomet recalls Arcos Modular Revision Hip System with porous plasma coating that may have insufficient adhesion strength due to rework process. Affected units include specific lot numbers and item numbers.
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 certain Arcos Modular Revision Hip Systems because the porous plasma coating may not stick properly after rework. This could lead to the implant failing in the body, causing pain or complications. Affected units have specific lot numbers and item numbers.
The porous plasma coating on the hip implant may not adhere properly to the metal base after rework. This could cause the coating to detach, leading to implant failure or complications. The issue arises from an unvalidated waterjet rework process used on the coating.
Patients who received the recalled Arcos Modular Revision Hip System with porous plasma coating. Those with the specific lot numbers and item numbers listed are most at risk.
Check for the lot numbers 853650 or 853810 and item number 11-301: 00880304468030(17) 290122(10)853650 or 00880304468030(17) 290211(10)853810 on the implant packaging.
Look for lot numbers 853650 or 853810 and item number 11-301301 on the implant packaging.
The porous plasma coating may not have sufficient adhesion strength after rework, which could lead to implant failure.
Check the product details for the specific lot numbers and item numbers listed. If you have the affected units, contact Biomet for further instructions.
The recall is for potential implant failure, but the official notice does not specify a risk of serious injury. The danger level is low risk.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0670-2022 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-0670-2022 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.
