Biomet recalls StageOne Shoulder Cement Spacer Mold 10mm (Item 431410) due to potential insufficient cleaning process or inadequate monitoring. Affected units 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 its StageOne Shoulder Cement Spacer Mold 10mm (Item 431410) because the cleaning process might not be thorough enough or monitoring might be inadequate. This could lead to contamination risks if the mold is used in medical procedures.
The mold may not be cleaned properly or the cleaning process might not be monitored correctly, leading to potential contamination. This could cause infections or other complications during medical procedures if the mold is used without adequate cleaning.
Medical professionals who use this mold for shoulder cement spacers during surgeries are most at risk. Patients using the mold in procedures are not directly affected but could face contamination risks if the mold is improperly cleaned.
Check for the product name 'StageOne Shoulder Cement Spacer Mold 10 MM' with dimensions 50 X 21 X 57 MM. Look for lot numbers listed in the recall (e.g., 860790, 215440) or UDI codes starting with (01)00880304551091.
Identify if your mold has the product name 'StageOne Shoulder Cement Spacer Mold 10 MM' with dimensions 50 X 21 X 57 MM and the listed lot numbers or UDI codes.
Biomet StageOne Shoulder Cement Spacer Mold 10 MM (50 X 21 X 57 MM), silicone, sterile, Item 431410.
Lot numbers 860790, 215440, 381650, and other specific numbers listed in the recall record.
Check the product name, dimensions, and lot numbers or UDI codes provided in the recall record.
The recall record does not specify a remedy, so contact Biomet directly for guidance.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1659-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-1659-2020 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.
