Biomet recalls StageOne Select hip stem cement spacer molds with reinforcement cement (item 431197) due to potential insufficient cleaning processes. Affected units have specific lot numbers and UDI codes. Consumers should check their product details.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Biomet is recalling StageOne Select hip stem cement spacer molds with reinforcement cement (item 431197) because the cleaning process might not be thorough enough. This could lead to contamination risks during surgical procedures. The recall affects specific lot numbers and UDI codes listed in the notice.
The recall is due to potential insufficient cleaning or inadequate monitoring of cleaning parameters during manufacturing. This could result in the molds being contaminated with harmful substances, which might pose a risk during surgical procedures if not properly cleaned.
Surgical equipment users and hospitals that have the specific lot numbers or UDI codes listed in the recall notice. Patients using these molds during hip surgery may be at risk if the molds are contaminated.
Check for the product name 'Biomet StageOne Select Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 200 MM, Silicone, Sterile, Item 431197' on the item. Affected units have specific lot numbers listed in the recall notice or UDI codes starting with (01)00880304521148.
Look for the product name and lot numbers listed in the recall notice to confirm if your item is affected.
Biomet is recalling these molds due to potential insufficient cleaning processes or inadequate monitoring of cleaning parameters, which could lead to contamination risks during surgical procedures.
Check the product name and lot numbers listed in the recall notice. Affected units have specific lot numbers or UDI codes starting with (01)00880304521148.
The recall notice does not specify a remedy, so you should check the product details to see if it is affected. If it is, contact Biomet 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-1650-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-1650-2020 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.
