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FDA-Device2025-12-31Class IIPROCESSING DEFECT

Zimmer Affixus Antegrade Femoral Nails recalled for potential shaft fracture

Zimmer Biomet
OTHERNationwide distribution

Contact your surgeon about Zimmer Affixus nail

Zimmer, Inc. recalled certain Affixus Antegrade Femoral Nails (9 mm, 360 mm length, left side) because the shaft may be undersized and could fracture over time. A fractured implant could cause pain, improper bone healing, or require additional surgery.

  • If you have had this implant surgically placed, contact your surgeon or orthopedic doctor immediately with your implant lot number
  • Your doctor can determine if your implant is affected and whether monitoring or replacement is needed
  • Keep your implant documentation and lot number (66717603, 66892902, or 67031550) available when you call
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: 815609360 Software Version: N/A Product Description: Affixus 9 mm, Length 360 mm, Left, Trochanteric Nail Component: N/A

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0977-2026

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