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FDA-Device2025-12-31Class IIPROCESSING DEFECT

Zimmer Affixus Antegrade Femoral Nailing System recalled for undersized shaft fracture risk

Zimmer Biomet
OTHERNationwide distribution

Contact your surgeon about Zimmer Affixus femoral nail

Zimmer, Inc. recalled specific lots of Affixus Antegrade Femoral Nails (9 mm, 340 mm, Left) because the implant shaft may be undersized. This could cause the nail to break over time after surgical implantation, potentially leading to pain, improper bone healing, or the need for additional surgery.

  • If you received this implant between the affected lot numbers, contact your orthopedic surgeon or hospital immediately
  • Ask your surgeon whether your implant is part of this recall by providing lot number 66717602 or 66892901
  • Do not delay—discuss next steps with your surgeon, including possible monitoring or replacement options
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
24
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: 815609340 Software Version: N/A Product Description: Affixus 9 mm, Length 340 mm, Left, Trochanteric Nail Component: N/A

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0976-2026

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