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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 nail

Zimmer, Inc. is recalling certain Affixus 9 mm femoral nails (Model 815509300, Lot 66717550) used in hip and thigh bone fracture surgery. Some implants may have a thinner-than-expected diameter that could cause the nail to fracture over time, potentially requiring additional surgery.

  • If you received this implant, contact your surgeon or orthopedic clinic immediately with your medical records
  • Do not delay—your doctor needs to verify if you have an affected implant
  • Your surgeon may recommend monitoring, imaging, or replacement depending on your situation
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
11
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: 815509300 Software Version: N/A Product Description: Affixus 9 mm, Length 300 mm, Right, Trochanteric Nail Component: N/A

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0983-2026

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