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FDA-Device2025-12-31Class IIPROCESSING DEFECT

Zimmer Affixus Antegrade Femoral Nailing System recalled for potential implant fracture

Zimmer Biomet
OTHERNationwide distribution

Contact your surgeon about Zimmer Affixus femoral nail

Zimmer, Inc. is recalling specific lots of the Affixus Antegrade Femoral Nailing System (a surgical implant used to stabilize thighbone fractures) because some units may have a manufacturing defect that could cause the implant to crack or break over time. If the implant breaks, it could lead to pain, improper bone healing, or the need for additional surgery.

  • If you or a family member has received this implant (model 815509420, 9 mm, 420 mm length, right side), contact your surgeon or the hospital where the procedure was performed immediately.
  • Ask your doctor whether your implant is part of the recalled lot numbers (66717556 or 66884566).
  • Do not attempt to remove or replace the implant yourself; follow your surgeon's guidance on next steps.
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: 815509420 Software Version: N/A Product Description: Affixus 9 mm, Length 420 mm, Right, Trochanteric Nail Component: N/A

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0972-2026

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