Recall Weekly← all recalls
FDA-Device2025-12-31Class IIPROCESSING DEFECT

Zimmer Affixus Antegrade Femoral Nails recalled for potential fatigue 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, 320 mm length, right-sided) because the implant shaft may be undersized. This manufacturing defect could cause the nail to break over time, which may lead to pain, bone healing problems, or the need for additional surgery.

  • If you have received this implant, contact your surgeon or orthopedic surgeon immediately
  • Do not delay medical care or remove the implant without consulting your doctor
  • Ask your surgeon whether your implant is affected (check lot numbers 66717551 or 66884561)
  • Follow your surgeon's guidance on monitoring or replacement options
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: 815509320 Software Version: N/A Product Description: Affixus 9 mm, Length 320 mm, Right, Trochanteric Nail Component: N/A

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0967-2026

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief