FDAFDA · Food and drugs·Recall number Z-0970-2026
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
Published December 31, 2025 · Recall initiated: December 2, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Zimmer, Inc.
- Distributor
- US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT.
- Lot
- Lot Code: Model No 815509380 ; UDI-DI (01)00887868143557(17)340822(10)66717554 ; Lot Number 66717554 Model No 815509380 ; UDI-DI (01)00887868143557(17)340822(10)66884564 ; Lot Number 66884564 Model No 815509380 ; UDI-DI (01)00887868143557(17)350421(10)67042197 ; Lot Number 67042197
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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