Biomet recalls StageOne Select Hip Stem Cement Spacer Mold w/Reinforcement Cement (13x145mm) due to potential insufficient cleaning process. Affected items have specific lot numbers and UDI codes. Consumers should check their product details and contact Biomet for guidance.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Biomet is recalling certain StageOne Select Hip Stem Cement Spacer Mold products because of a potential issue with the cleaning process that might not be thorough enough. This could lead to contamination risks during medical procedures. Affected items have specific lot numbers and UDI codes listed in the recall.
The recall is due to a potential insufficient cleaning process or inadequate monitoring of cleaning parameters. This could result in the mold not being properly cleaned, increasing the risk of contamination during surgical procedures.
Medical professionals who use this hip implant mold in surgeries are most at risk. Patients who have received this mold in their procedures may also be affected if the mold was contaminated.
Check the product label for lot numbers listed in the recall (e.g., 838930, 799860, etc.) or UDI numbers starting with (01)00880304521247. The product is a silicone hip stem cement spacer mold used in medical procedures.
Look for lot numbers or UDI codes on the product label to determine if it's affected. Affected items have specific lot numbers and UDI codes listed in the recall.
Biomet is recalling StageOne Select Hip Stem Cement Spacer Mold w/Reinforcement Cement (13x145mm) silicone, sterile items with specific lot numbers and UDI codes.
Check the product label for lot numbers listed in the recall (e.g., 838930, 799860) or UDI numbers starting with (01)00880304521247.
Contact Biomet directly for guidance on next steps. The recall does not include a specific remedy, so they will provide instructions.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1645-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-1645-2020 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.
