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FDA-Device2025-12-31Class IIPROCESSING DEFECT

Zimmer Affixus Antegrade Femoral Nailing System recalled for fracture risk

Zimmer Biomet
OTHERNationwide distribution

Contact your surgeon about Zimmer Affixus nail

Zimmer, Inc. is recalling specific Affixus Antegrade Femoral Nailing System implants (model 815609380, 9 mm, 380 mm length, left side) because they may have a manufacturing defect that makes the shaft undersized. This defect could cause the implant to break over time, potentially requiring additional surgery.

  • If you received this implant, contact your surgeon immediately with your implant information
  • Do not attempt to remove or replace the implant yourself—only a surgeon should do this
  • Ask your surgeon whether your specific implant lot is affected and if monitoring or replacement is needed
  • Keep your implant documentation and lot number available when you contact your healthcare provider
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: 815609380 Software Version: N/A Product Description: Affixus 9 mm, Length 380 mm, Left, Trochanteric Nail Component: N/A

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0978-2026

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