Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails M
Pending LLM rewrite. Source: FDA_DEVICE Z-0978-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
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.
The recalled product
- Product
- Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609380 Software Version: N/A Product Description: Affixus 9 mm, Length 380 mm, Left, Trochanteric Nail Component: N/A
- Manufacturer
- Zimmer, Inc.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lot Code: Model No 815609380
- UDI-DI (01)00887868144509(17)340826(10)66717604
- Lot Number 66717604 Model No 815609380
- UDI-DI (01)00887868144509(17)340820(10)66892903
- Lot Number 66892903
Distribution
Distributed nationwide across the United States.
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