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FDA-Device2025-12-31Class IIPROCESSING DEFECT

Zimmer Affixus Antegrade Femoral Nails recalled for fracture risk

Zimmer Biomet
OTHERNationwide distribution

Contact your surgeon about Zimmer femoral nail

Zimmer, Inc. recalled 22 Affixus Antegrade Femoral Nails (9 mm, 340 mm length, right-sided) because the implants may have an undersized shaft diameter that could cause the nail to break inside the leg over time. If the implant fractures, it may cause pain, improper bone healing, tissue damage, or require additional surgery.

  • If you received this implant, contact your surgeon immediately with lot number 66717552 or 66884562
  • Your surgeon will determine if you need imaging or follow-up care
  • Do not delay—discuss your implant and any leg pain or discomfort with your doctor
Hazard

Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

Sold states
US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT.
Affected count
22
Manufactured in
1800 W Center St, N/A, Warsaw, IN, United States
Products
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509340 Software Version: N/A Product Description: Affixus 9 mm, Length 340 mm, Right, Trochanteric Nail Component: N/A

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0968-2026

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