Biomet recalls StageOne Hip Cement Spacer Mold w/Reinforcement (Item 431213) due to potential insufficient cleaning process or inadequate monitoring of cleaning parameters. Affected units have specific lot numbers and UDI codes.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Biomet is recalling certain StageOne Hip Cement Spacer Mold products because they may not have been cleaned properly during manufacturing. This could lead to contamination risks for patients using these medical devices. If you own one of the affected models, you should contact Biomet for details.
The mold may not have been cleaned thoroughly during manufacturing, or the cleaning process monitoring may have been inadequate. This could lead to contamination risks for patients using the device.
Patients who have received this specific hip cement spacer mold during surgery are most at risk. The recall affects medical devices used in hip replacement procedures.
Check for the product name 'StageOne Hip Cement Spacer Mold w/Reinforcement', size 13 X 145 MM, 57 MM, and the specific lot numbers listed in the recall notice. Also look for the UDI codes provided in the record.
Reach out to Biomet directly for instructions on how to verify if your device is affected and what to do next.
The recall indicates potential cleaning issues, but the product is not unsafe to use. Affected units should be contacted for further instructions.
Check the lot numbers and UDI codes listed in the recall notice. The affected units have specific lot numbers and UDI codes provided in the record.
Contact Biomet directly for instructions on how to verify if your device is affected and what to do next.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1655-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-1655-2020 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.
