Femoral nails, 280 mm left piriformis, recalled over undersized shaft diameter
Zimmer is recalling 3 Affixus Antegrade Femoral Nails, model 815809280, because an undersized distal shaft diameter could lead to implant fatigue fracture.
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: Scored 3 under the risk-of-harm criterion: the firm states an undersized shaft could cause implant fatigue fracture requiring surgical intervention, and no injuries are reported.
Plain-English summary
The Affixus Antegrade Femoral Nail, model 815809280, described in the record as Affixus 9 mm, Length 280 mm, Left, Piriformis Nail, is being recalled by Zimmer, Inc.
Affected implants may have an undersized distal diameter along the length of the shaft, which the firm states could lead to implant fatigue fracture. Zimmer lists the potential health risks if an implant fatigue fracture occurs as adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
The record lists 3 units, carrying UDI-DI (01)00887868584763(17)350416(10)67066287 from lot 67066287. Distribution was nationwide in the United States, in Alabama, Arizona, California, Florida, Indiana, Kentucky, Massachusetts, Missouri, Montana, North Carolina, New Mexico, Rhode Island, Texas and Utah. The FDA has classified the action as Class II.
The enforcement record reports no injuries. Facilities should quarantine affected stock and follow Zimmer's instructions.
The recalled product
- Product
- Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815809280 Software Version: N/A Product Description: Affixus 9 mm, Length 280 mm, Left, Priformis Nail Component: N/A
- Manufacturer
- Zimmer, Inc.
- Affected units
- 3
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 (3)
- Lot Code: Model No 815809280
- UDI-DI (01)00887868584763(17)350416(10)67066287
- Lot Number 67066287
Distribution
Part of a larger recall action
This product is one of 17 recalled by Zimmer, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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