Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Defect
Zimmer Biomet is recalling Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.
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, and the defect involves a structural failure of a medical implant (set screw malfunction) which poses a risk of harm, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Zimmer Biomet, Inc. is recalling 5,947 units of the Affixus Hip Fracture Nail Left 130° 11 mm x 380 mm (Item Number: 814611380). The recall was initiated because the set screw is not able to advance or reverse from the original position in the nail.
The affected products were distributed to 38 U.S. states and Puerto Rico, as well as to Chile, Ecuador, Japan, and the Netherlands. The source text does not specify the number of patients affected or report any injuries or illnesses associated with this defect.
Healthcare providers and patients should contact Zimmer Biomet for further instructions on how to manage the recalled devices. The source text does not provide specific consumer action steps beyond the standard recall notification.
The recalled product
- Product
- Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 380 mm, Item Number: 814611380
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 5,947
Distribution
Part of a larger recall action
This product is one of 129 recalled by Zimmer Biomet, 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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