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FDA-Device2025-12-31Class IIPROCESSING DEFECT

Zimmer Affixus Antegrade Femoral Nails recalled for fracture risk

Zimmer Biomet
OTHERNationwide distribution

Contact your surgeon about Zimmer femoral nail

Zimmer has recalled certain Affixus Antegrade Femoral Nails (model 815609440) used in hip fracture surgery. Some implants may have a manufacturing defect that makes them thinner than intended, which could cause the implant to crack or break over time. This could lead to pain, improper healing, or the need for additional surgery.

  • If you had hip fracture surgery with a Zimmer Affixus nail, contact your surgeon immediately.
  • Your surgeon can determine if your implant is affected using the lot number or product code.
  • Do not delay—discuss symptoms like hip pain, ache, or difficulty with healing with your doctor right away.
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: 815609440 Software Version: N/A Product Description: Affixus 9 mm, Length 440 mm, Left, Trochanteric Nail Component: N/A

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0981-2026

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