Zimmer Biomet recalls Affixus Hip Fracture Nail Right 125 (11mm x 440mm) 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 Right 125 (11mm x 440mm) because the set screw can't move forward or backward properly. This could lead to improper fixation of the hip fracture, risking complications during surgery or after the procedure.
The set screw in the nail cannot advance or reverse from its original position. This means the nail might not hold securely in the bone, potentially causing the implant to shift during healing or movement. If the nail shifts, it could lead to complications like pain, infection, or the need for additional surgery.
Surgical patients who received this specific hip fracture nail implant during procedures between 2019 and 2023 are likely affected. Patients who have had the implant are at risk of improper fixation if the set screw malfunctions.
Check for the product name 'Affixus Hip Fracture Nail Right 125' with dimensions 11 mm x 440 mm and item number 814311440. This recall applies to units sold between 2019 and 2023.
Verify the item number 814311440 and dimensions 11 mm x 440 mm on the implant.
This recall affects surgical patients who received the Affixus Hip Fracture Nail Right 125 (11 mm x 440 mm) with item number 814311440 between 2019 and 2023.
The official recall notice does not specify a remedy, so contact Zimmer Biomet directly for guidance.
Check the item number 814311440 and dimensions 11 mm x 440 mm on your implant. This recall applies to units sold between 2019 and 2023.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-3064-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-3064-2018 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.