Home / Recalls / Zimmer, Inc. / Z-0971-2026

Z-0971-2026 Class II Ongoing

Recalled by Zimmer, Inc. — Warsaw, IN

Recall Details

Product Type
Devices
Report Date
December 31, 2025
Initiation Date
December 2, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
23

Product Description

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509400 Software Version: N/A Product Description: Affixus 9 mm, Length 400 mm, Right, Trochanteric Nail Component: N/A

Reason for Recall

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.

Distribution Pattern

US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT.

Code Information

Lot Code: Model No 815509400 ; UDI-DI (01)00887868143564(17)340821(10)66717555 ; Lot Number 66717555 Model No 815509400 ; UDI-DI (01)00887868143564(17)340822(10)66884565 ; Lot Number 66884565 Model No 815509400 ; UDI-DI (01)00887868143564(17)350801(10)67379212 ; Lot Number 67379212

Other recalls by Zimmer, Inc.

  • Z-0969-2026 Class II — Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Anteg (December 2, 2025)
  • Z-0974-2026 Class II — Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Anteg (December 2, 2025)
  • Z-0978-2026 Class II — Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Anteg (December 2, 2025)
  • Z-0977-2026 Class II — Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Anteg (December 2, 2025)
  • Z-0975-2026 Class II — Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Anteg (December 2, 2025)
  • Z-0982-2026 Class II — Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Anteg (December 2, 2025)
  • Z-0980-2026 Class II — Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Anteg (December 2, 2025)
  • Z-0983-2026 Class II — Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Anteg (December 2, 2025)
  • Z-0981-2026 Class II — Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Anteg (December 2, 2025)
  • Z-0968-2026 Class II — Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Anteg (December 2, 2025)