Zimmer Biomet recalls 125 left hip fracture nails (item 814411340) due to sterile packaging opening during surgery. Affected units have lot numbers 244280, 558120, or 558130.
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
Zimmer Biomet is recalling 125 left hip fracture nails that may have had sterile packaging open during surgery. This could lead to infection risks if the device is used without proper sterility.
The sterile packaging was found open during surgery, which could allow contamination. This might lead to infection if the nail is implanted without proper sterility.
Patients who received the recalled left hip fracture nails (item 814411340) with lot numbers 244280, 558120, or 558130. Surgeons and medical staff using these specific units are most at risk.
Check for the product name 'Affixus Hip Fracture Nail - Left', size 125 11mm x 340mm, and item number 814411340. Affected units have lot numbers 244280, 558120, or 558130.
Verify if the packaging was open during surgery by checking with your surgeon or medical records.
The recall indicates potential contamination risk if the sterile packaging was open during surgery. Consult your surgeon for specific guidance.
Look for the product name 'Affixus Hip Fracture Nail - Left', size 125 11mm x 340mm, item number 814411340, and lot numbers 244280, 558120, or 558130.
The recall does not require immediate discontinuation. Contact your surgeon to determine if the product was used with open packaging.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0152-2019 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0152-2019 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.