Zimmer, Inc.: Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609400 Software
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Zimmer, Inc.
- Product
- Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609400 Software Version: N/A Product Description: Affixus 9 mm, Length 400 mm, Left, Trochanteric Nail Component: N/A
- Reason / 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT.
- Recall initiated
- 2025-12-02
- Code info
- Lot Code: Model No 815609400 ; UDI-DI (01)00887868144516(17)340818(10)66717605 ; Lot Number 66717605 Model No 815609400 ; UDI-DI (01)00887868144516(17)340826(10)66892904 ; Lot Number 66892904 Model No 815609400 ; UDI-DI (01)00887868144516(17)341024(10)67031552 ; Lot Number 67031552
- Product quantity
- 24
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Warsaw
- State
- IN
- Country
- United States
- Event id
- 98069
Free daily digest + "My products" watchlist