Zimmer Biomet recalls Affixus Hip Fracture Nail Right 130 (11mm x 38: 814511380) 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 a specific hip fracture nail model because the set screw cannot move correctly. This could lead to improper fixation of the hip fracture, risking complications during healing.
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 complications during healing or requiring additional surgery.
Orthopedic surgeons and medical professionals who use this specific hip fracture nail model are affected. Patients receiving this implant are at risk if the set screw malfunctions.
Check for the model name 'Affixus Hip Fracture Nail Right 130', size 11 mm x 380 mm, and item number 814511380. The product was sold under specific codes: 054200, 054210, 054220, 519620, 519630, 813210.
Verify the model name, size, and item number to confirm if your product is affected.
The recall is for a potential issue with the set screw not advancing or reversing properly, which could lead to improper fixation. However, the hazard is not described as causing serious injury in normal use, so the risk level is low.
Check for the model name 'Affixus Hip Fracture Nail Right 130', size 11 mm x 380 mm, and item number 814511380. The product was sold under specific codes: 054200, 054210, 054220, 519620, 519630, 813210.
The recall does not specify a remedy, so affected users should check with Zimmer Biomet 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-3127-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-3127-2018 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.
