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FDA-Device2025-12-31Class IIPROCESSING DEFECT

Zimmer Affixus Antegrade Femoral Nails recalled for potential fracture risk

Zimmer Biomet
OTHERNationwide distribution

Contact your surgeon about Zimmer femoral nail implant

Zimmer, Inc. is recalling certain Affixus Antegrade Femoral Nails (model 815509440, 440 mm length) because the implant shaft may be undersized. This defect could cause the nail to break over time, potentially leading to pain, improper bone healing, or the need for additional surgery.

  • If you received this implant, contact your surgeon or orthopedic doctor immediately
  • Provide your surgeon with the lot number from your medical records or implant card
  • Do not delay—discuss monitoring or replacement options with your healthcare provider
  • Ask your surgeon whether imaging (X-rays) is needed to check your implant
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: 815509440 Software Version: N/A Product Description: Affixus 9 mm, Length 440 mm, Right, Trochanteric Nail Component: N/A

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0973-2026

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