Zimmer Biomet recalls Affixus Hip Fracture Nail Left 125 (13mm x 420mm) 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 125 (13mm x 420mm) because the set screw can't move correctly. This could lead to improper fixation of the hip fracture, risking complications during surgery or recovery.
The set screw in the nail fails to advance or reverse from its original position. This could cause the nail to become improperly fixed in the bone, potentially leading to displacement or failure during healing.
Patients who received this specific hip fracture nail implant during surgery are affected. Surgeons and medical staff using the product for hip fracture repairs are most at risk.
Check for the product name 'Affixus Hip Fracture Nail Left 125' with dimensions 13 mm x 420 mm. The item number 814413420 is also listed on the packaging.
Verify the product name, dimensions, and item number on the packaging to confirm if it matches the recalled item.
The recall states the set screw may not advance or reverse correctly, which could lead to improper fixation. However, the product is not inherently dangerous if used correctly by trained medical professionals.
The recall record does not specify a remedy, so Zimmer Biomet has not provided instructions for replacement or repair.
The recall record does not state a specific action for affected users, so contact Zimmer Biomet directly for guidance.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-3106-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-3106-2018 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.