Zimmer Affixus Femoral Nails Risk of Fatigue Fracture
Zimmer is recalling Affixus Antegrade Femoral Nails due to undersized distal diameter that could cause implant fatigue fracture. Affected patients may experience pain, non-union, tissue damage, and may require surgical intervention.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of an orthopedic implant with potential for serious complications including surgical intervention and tissue damage. No injuries have been reported to date, but the product poses a clear risk of harm. Per the rubric, risk-of-harm products where injury has not yet been reported score as High (3).
Plain-English summary
Zimmer, Inc. is recalling the Affixus Antegrade Femoral Nailing System (model 815609360, 9 mm, 360 mm length, left trochanteric nail). Affected implants may have undersized distal diameter along the shaft, which could lead to implant fatigue fracture. This defect poses potential health risks including adverse local tissue reaction, pain or ache, non-union or malunion, and tissue damage requiring surgical intervention.
Twenty-four units were distributed nationwide across 14 states: Alabama, Arizona, California, Florida, Indiana, Kentucky, Massachusetts, Missouri, Montana, North Carolina, New Mexico, Rhode Island, Texas, and Utah. The affected lot numbers are 66717603, 66892902, and 67031550.
The recalled product
- Product
- Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609360 Software Version: N/A Product Description: Affixus 9 mm, Length 360 mm, Left, Trochanteric Nail Component: N/A
- Manufacturer
- Zimmer, Inc.
- Hazard
- implant-fatigue-fracture
- undersized-diameter
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 (7)
- Lot Code: Model No 815609360
- UDI-DI (01)00887868144493(17)340820(10)66717603
- Lot Number 66717603 Model No 815609360
- UDI-DI (01)00887868144493(17)340905(10)66892902
- Lot Number 66892902 Model No 815609360
- UDI-DI (01)00887868144493(17)341030(10)67031550
- Lot Number 67031550
Distribution
Distributed nationwide across the United States.
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