Zimmer Biomet recalls Affixus Hip Fracture Nails with open sterile packaging during surgery. Affected lot numbers 450770 and 450790. 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 or contamination since the packaging was not properly sealed before use.
The sterile packaging was already open when the product was used in surgery. This means the nail could be contaminated before it was implanted, increasing the risk of infection or other complications for the patient.
Patients who received the Affixus Hip Fracture Nail Right 125 (9 mm x 320 mm) with lot numbers 450770 or 450790 during surgery are affected. Surgeons and surgical teams using these specific lot numbers are at highest risk.
Check if your hip fracture nail has the model 'Affixus Hip Fracture Nail Right 125 (9 mm x 320 mm)' and lot numbers 450770 or 450790. The product was sold for surgical use only.
Look for lot numbers 450770 or 450790 on the packaging to confirm if your product is affected.
The recall notice does not specify any remedy or fix for this issue.
Check for lot numbers 450770 or 450790 on the packaging of the Affixus Hip Fracture Nail Right 125 (9 mm x 320 mm).
The recall notice does not specify any action steps for affected products.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0125-2019 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0125-2019 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.
