Biomet recalls custom hip implants due to potential cleaning process issues. Affected items may have inadequate sterilization, risking infection. Contact Biomet for details.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Biomet is recalling custom hip implants that may not have been cleaned properly, increasing infection risk. This affects surgeons and hospitals using the specific implant model.
The implant may not have been cleaned thoroughly during manufacturing, which could lead to contamination. This increases the risk of infection if the implant is used in surgery without proper sterilization.
Surgeons and hospitals using the specific hip implant model (9 x 125 mm stainless steel) are most at risk. The recall targets medical facilities that use this implant during surgeries.
Check for the model '9 X 125 MM, Stainless Steel, PMI Instrument, Sterile' with lot number 800940. This implant is used in hip surgeries and sold by Biomet.
Look for the model number 9 X 125 MM, stainless steel, PMI instrument, sterile, and lot number 800940 on the implant packaging.
The recall indicates potential cleaning issues, but the implant may still be safe if used properly. Biomet recommends checking for the specific lot number.
The recall record does not specify a replacement process or remedy.
Biomet is the manufacturer and should be contacted for details about the recall.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1670-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-1670-2020 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.
