Biomet recalls StageOne Select hip stem cement spacer molds with specific lot numbers due to potential insufficient cleaning processes. Consumers should check their product details to determine if affected.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Biomet is recalling certain hip stem cement spacer molds that may have insufficient cleaning processes, which could lead to contamination. This recall affects specific lot numbers and UDI codes.
The recall is due to potential insufficient cleaning processes or inadequate monitoring of cleaning parameters during manufacturing. This could result in contamination of the molds, but the hazard is not described as causing serious injury or death in normal use.
Patients who received the recalled hip stem cement spacer molds for hip surgery are most at risk. The recall applies to specific lot numbers and UDI codes listed in the notice.
Check the lot numbers listed in the recall notice (e.g., 978860, 087790) or the UDI numbers provided. The product is a silicone hip stem cement spacer mold used in hip surgery.
Identify if your hip stem cement spacer mold has the listed lot numbers or UDI codes from the recall notice.
The recall is due to potential insufficient cleaning processes or inadequate monitoring of cleaning parameters during manufacturing.
Check the lot numbers or UDI codes listed in the recall notice (e.g., 978860, 087790, or UDI numbers starting with (01)00880304521155).
The recall does not specify a remedy, so contact Biomet directly for further instructions.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1647-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-1647-2020 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.
