Zimmer Biomet Recalls AFFIXUS Hip Fracture Nail Due to Sizing Defect
Zimmer Biomet is recalling 33,500 AFFIXUS Hip Fracture Nail units worldwide because certain undersized specifications may prevent the nail from properly engaging with the targeting jig.
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: The recall is classified as FDA Class II. The hazard involves a mechanical defect in a surgical implant that could lead to improper placement, but the source text does not report any specific injuries, illnesses, or deaths, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zimmer Biomet, Inc. is recalling 33,500 units of the AFFIXUS Hip Fracture Nail System. The recall covers distribution in the United States and several international markets, including Australia, Canada, Chile, Colombia, Costa Rica, the Netherlands, Japan, Spain and the Canary Islands, Switzerland, and the United Kingdom.
The recall is being issued because the nail may not properly engage with the targeting jig due to certain undersized specifications. The AFFIXUS Hip Fracture Nail System is intended to treat stable and unstable proximal fractures of the femur, including pertrochanteric, intertrochanteric, and high subtrochanteric fractures.
The source text does not report any specific injuries, illnesses, or deaths associated with this defect. Consumers and healthcare providers should check their inventory against the extensive list of affected lot numbers provided in the official recall notice and contact Zimmer Biomet for further instructions.
The recalled product
- Product
- AFFIXUS Hip Fracture Nail Product Usage: The Hip Fracture Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, interochanteric fractures, high subtrochanteric fractures and combinations of these fractures, i
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 33,500
Distribution
Distributed nationwide across the United States.
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