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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 femoral nail

Zimmer, Inc. is recalling certain Affixus Antegrade Femoral Nails (9 mm, 380 mm length, right-sided) because the implant shaft may be undersized. This manufacturing defect could cause the implant to break inside the body, potentially leading to pain, improper bone healing, or the need for additional surgery.

  • Contact your orthopedic surgeon immediately if you have received this implant
  • Ask your surgeon to verify your implant's lot number against the recalled batches (66717554, 66884564, or 67042197)
  • Do not delay—seek medical evaluation if you experience thigh pain, ache, or swelling around the surgical site
  • Keep your surgical records and implant documentation available for your doctor
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: 815509380 Software Version: N/A Product Description: Affixus 9 mm, Length 380 mm, Right, Trochanteric Nail Component: N/A

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0970-2026

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