Zimmer Biomet recalls Affixus Hip Fracture Nail Right 130 (11mm x 360mm) due to set screw not advancing or reversing properly. Affected units sold between 2019-2023; contact for replacement.
The set screw is not able to advance or reverse from the original position in the nail.
Zimmer Biomet is recalling Affixus Hip Fracture Nail Right 130 models because the set screw can't move forward or backward properly. This could lead to improper fixation of the hip fracture nail, risking complications during surgery or after implantation.
The set screw in the nail cannot advance or reverse from its original position. This means the nail may not secure properly during surgery, potentially causing improper fixation of the hip fracture. If the nail isn't fixed correctly, it could lead to complications like displacement or failure to hold the bone fragments together.
Surgical patients who received the Affixus Hip Fracture Nail Right 130 (11mm x 360mm) model during surgery between 2019 and 2023 are most at risk. Healthcare providers using this specific implant are also affected.
Check for the model name 'Affixus Hip Fracture Nail Right 130' with dimensions 11 mm x 360 mm. The item number is 814511360. Units were sold between 2019 and 2023.
Reach out to Zimmer Biomet directly for replacement or further instructions.
The recall is for a potential issue with the set screw that could affect proper fixation during surgery, but the hazard is not described as causing serious injury in normal use.
Check for the model name 'Affixus Hip Fracture Nail Right 130' with dimensions 11 mm x 360 mm and item number 814511360. Units were sold between 2019 and 2023.
The recall does not specify a need to stop using the implant immediately; contact Zimmer Biomet for replacement or 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-3126-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-3126-2018 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.