Zimmer Biomet recalls Affixus Hip Fracture Nail Left 130 (13mm x 260mm) due to set screw not advancing or reversing properly. Affected units may need repair or 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 260mm) because the set screw cannot advance or reverse from its original 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 cannot move forward or backward from its starting position. This may prevent the nail from being properly secured in the bone, which could lead to the implant shifting or failing during healing.
Patients who received this specific hip fracture nail implant during surgery are affected. Surgeons and medical staff who used this model during procedures are at higher risk.
Check for the model name 'Affixus Hip Fracture Nail Left 130' with dimensions 13 mm x 260 mm. The item number is 814613260. This product was sold by Zimmer Biomet.
Verify the model name, dimensions, and item number to confirm if your product is affected.
The recall states the set screw may not advance or reverse from its original position, but it does not indicate that the product is unsafe when used correctly.
The recall record does not specify a remedy or replacement process.
The recall record does not provide specific action steps for affected users.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-3163-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-3163-2018 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.
