Biomet recalls StageOne Shoulder Cement Spacer Mold 6 MM (Item 431406) due to potential insufficient cleaning process. Affected units have specific lot numbers and UDI codes. Consumers should check their product details to determine if recalled.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Biomet is recalling its StageOne Shoulder Cement Spacer Mold 6 MM (42 x 18 x 46 mm, silicone, sterile) because the cleaning process might not be thorough enough. This could lead to contamination risks if the mold is used in medical procedures without proper sanitation.
The mold may not be cleaned properly during manufacturing, which could lead to contamination. If used without adequate cleaning, it might introduce harmful bacteria or particles into the surgical site.
Medical professionals who use this mold for shoulder cement spacers during surgeries are most at risk. The recall affects specific units with listed lot numbers and UDI codes.
Check the lot numbers listed in the recall (e.g., 860650, 215420) or the UDI codes (e.g., (01)00880304551107(17)141007(10)860650). The product is a silicone, sterile mold used in shoulder cement spacers.
Identify if your mold has a lot number or UDI code from the list provided in the recall notice.
The recall indicates potential cleaning issues, but the product is generally safe if used properly. Affected units should be checked against the listed lot numbers and UDI codes.
Check the lot numbers or UDI codes on your mold against the list provided in the recall notice.
The recall does not specify a remedy, so contact Biomet directly to determine if your specific unit is affected.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1657-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-1657-2020 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.
