Zimmer Biomet recalls Affixus Hip Fracture Nail Right 125 (11mm x 380mm) due to set screw not advancing or reversing properly. Affected units have item number 814311380.
The set screw is not able to advance or reverse from the original position in the nail.
Zimmer Biomet is recalling Affixus Hip Fracture Nails Right 125 (11mm x 3:80mm) because the set screw cannot move forward or backward from its starting position. This could lead to improper fixation of the hip fracture, potentially causing complications during surgery or after the procedure.
The set screw in the nail is designed to be tightened or loosened to secure the implant. If it cannot advance or reverse from its original position, the nail may not hold properly during surgery or after implantation, increasing the risk of improper fixation and potential complications.
Patients who received the Affixus Hip Fracture Nail Right 125 (11mm x 380mm) with item number 814311380 from Zimmer Biomet. Surgeons and medical staff using this specific nail during hip fracture procedures are most at risk.
Check for the product name 'Affixus Hip Fracture Nail Right 125' with dimensions 11 mm x 380 mm and item number 814311380. This specific model was sold in the United States between 2013 and 2018.
Verify the item number 814311380 on the nail packaging or label to confirm if it is affected.
This recall applies to the specific Affixus Hip Fracture Nail Right 125 model. If you received this exact model during surgery, contact Zimmer Biomet for guidance.
Check for the item number 814311380 on the nail packaging or label. This model was sold between 2013 and 2018.
The recall does not specify a remedy, so contact Zimmer Biomet directly for further instructions.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-3061-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-3061-2018 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.
