Zimmer Biomet recalls Affixus Hip Fracture Nails with open sterile packaging during surgery. Affected items have lot numbers 584760 or 584770. 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 may have open sterile packaging during surgery. This could lead to infection risks if the product is used without proper sterility.
The sterile packaging may be open during surgery, which could lead to contamination. This increases the risk of infection if the nail is not properly sterilized before use.
Surgical teams using Affixus Hip Fracture Nails with lot numbers 584760 or 584770 are affected. Patients undergoing hip fracture surgery with these specific items face the highest risk.
Check for lot numbers 584760 or 584770 on the Affixus Hip Fracture Nail packaging. The product is intended for hip fracture fixation and has a specific size (125 9 mm x 460 mm).
Look for lot numbers 584760 or 584770 on the packaging to identify affected items.
The recall notice does not specify any remedy.
The sterile packaging may be open during surgery, which could lead to contamination and infection risks.
Lot numbers 584760 and 584770.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0149-2019 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0149-2019 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.