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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 lots of Affixus Antegrade Femoral Nails (model 815509400, 9 mm, 400 mm length) used in thigh bone surgery. Some implants may have a manufacturing defect that makes the shaft undersized, which could cause the nail to fracture over time.

  • If you had thigh bone surgery with an Affixus nail, contact your surgeon or orthopedic doctor immediately with your implant lot number
  • Ask your doctor to verify whether your implant is from one of the affected lots (66717555, 66884565, or 67379212)
  • Follow your doctor's guidance on whether monitoring, imaging, or replacement surgery is needed
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
23
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: 815509400 Software Version: N/A Product Description: Affixus 9 mm, Length 400 mm, Right, Trochanteric Nail Component: N/A

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0971-2026

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