Zimmer Biomet recalls Affixus Hip Fracture Nail Left 130 (13mm x 380mm) due to set screw not advancing or reversing properly. Affected units may need replacement.
The set screw is not able to advance or reverse from the original position in the nail.
Zimmer Biomet is recalling Affix:us Hip Fracture Nails Left 130 (13mm x 380mm) because the set screw can't move properly. This could lead to improper fixation of the hip fracture, risking complications during surgery or recovery.
The set screw in the nail cannot advance or reverse from its original position. This means the nail might not hold securely in the bone, potentially causing the implant to shift during surgery or after the procedure. While the hazard is serious for surgical use, it does not pose an immediate risk to patients outside of the operating room.
Orthopedic surgeons and medical staff who use this specific hip fracture nail during surgery are affected. Patients receiving this implant are at risk if the set screw malfunctions during the procedure.
Check for the product name 'Affixus Hip Fracture Nail Left 130' with dimensions 13 mm x 380 mm. The item number 814613380 is also associated with this recall.
Reach out to Zimmer Biomet directly for guidance on the recall and potential replacement options.
The recall indicates the set screw may not function properly, so it is not recommended for use until a replacement is provided.
Look for the product name 'Affixus Hip Fracture Nail Left 130' with dimensions 13 mm x 380 mm and item number 814613380.
Contact Zimmer Biomet directly for guidance on the recall and potential replacement options.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-3169-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-3169-2018 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.
