Zimmer, Inc. — Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609420 Software Version: N/A Product Description: Affixus 9 m
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- December 2, 2025
US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT.
What's affected?
- Product
- Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609420 Software Version: N/A Product Description: Affixus 9 mm, Length 420 mm, Left, Trochanteric Nail Component: N/A
- Brand
- Zimmer, Inc.
- Lot code
- Model
Additional details
Lot Code: Model No 815609420 ; UDI-DI (01)00887868144523(17)340818(10)66717606 ; Lot Number 66717606 Model No 815609420 ; UDI-DI (01)00887868144523(17)340913(10)66892905 ; Lot Number 66892905
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 23.
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