Zimmer Biomet recalls Affixus Hip Fracture Nails with open sterile packaging during surgery. Affected lot numbers: 343590, 343610. 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 or contamination if used without proper sterilization.
The sterile packaging may have been open during surgery, which could allow contamination. If the packaging is not properly sealed, the surgical site might become infected during the procedure.
Surgical teams using the Affixus Hip Fracture Nails with lot numbers 343590 or 343610 are affected. Patients undergoing hip fracture surgery with these specific lot numbers are at risk of infection.
Check the lot number on the packaging. Affected items have lot numbers 343590 or 343610. The product is an Affixus Hip Fracture Nail Right 130, 11 mm x 360 mm, with item number 814511360.
Look for lot numbers 343590 or 343610 on the packaging.
The recall is due to complaints that the sterile packaging was already open during surgery, which could lead to contamination.
The recall notice does not specify a remedy, so contact Zimmer Biomet directly for guidance.
The recall indicates a potential for contamination during surgery, but the notice does not specify if this causes serious injury.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0161-2019 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0161-2019 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.
