Biomet recalls StageOne Hip Cement Spacer Mold w/Reinforcement (9x125mm, 51mm, silicone) with lot numbers 411170, 928060, and others due to potential insufficient cleaning process or inadequate monitoring. No remedy specified in recall.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Biomet is recalling StageOne Hip Cement Spacer Mold products that may have insufficient cleaning or inadequate monitoring during production. This could lead to contamination risks, but no specific injuries have been reported. Affected units have specific lot numbers and UDI codes.
The recall is due to potential insufficient cleaning process or inadequate monitoring of cleaning parameters during manufacturing. This could result in the mold being contaminated, which might pose a risk during surgical procedures.
Medical professionals using Biomet StageOne Hip Cement Spacer Mold products for hip surgeries are most at risk. Patients using these molds during surgery may be affected if the product is contaminated.
Check for lot numbers listed in the recall (e.g., 411170, 928060) or UDI numbers starting with (01)00880304447141. The product is a silicone hip cement spacer mold used in hip surgery.
Look for lot numbers on the product or UDI codes starting with (01)00880304447141 to determine if it's affected.
The recall indicates potential cleaning issues, but no specific injuries have been reported. Affected units should be checked for lot numbers or UDI codes.
Check the product for lot numbers or UDI codes listed in the recall. If it matches, contact Biomet for guidance.
The recall record states no remedy is provided.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1654-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-1654-2020 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.
