Zimmer Biomet recalls Affixus Hip Fracture Nails with open sterile packaging during surgery. Affected lot numbers: 616460. No remedy specified in recall notice.
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
Zimmer Biomet is recalling hip fracture nails that were found to have open sterile packaging during surgery. This could lead to infection risks if the product was used without proper sterilization.
The sterile packaging was found open during surgery, meaning the product might not have been properly sterilized. This could lead to infection if the nail is used without a clean, sterile environment.
Surgical teams using the Affixus Hip Fracture Nails with lot number 616460 are affected. Patients undergoing hip fracture surgery with this specific product are at risk of infection.
Check for the product name 'Affixus Hip Fracture Nail Left 130 9 mm x 360 mm' with item number 814609360. The affected lot number is 616460.
Verify the lot number on the packaging to see if it matches 616460.
The recall indicates the packaging was open during surgery, but the product itself is not inherently dangerous if used correctly.
The recall notice does not specify a remedy, so no action is required beyond checking the lot number.
Check the lot number on the packaging; affected units have lot number 616460.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0164-2019 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0164-2019 from Zimmer 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.
