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 component (set screw) of a medical device used in hip fractures, which poses a risk of harm even without reported injuries.
Plain-English summary
Zimmer Biomet, Inc. is recalling 5,947 units of the Affixus Hip Fracture Nail Right 125° 9 mm x 360 mm (Item Number: 814309360). 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 41 U.S. states and Puerto Rico, as well as to Chile, Ecuador, Japan, and the Netherlands. The recall is classified as Class II by the U.S. Food and Drug Administration.
Healthcare providers and patients should contact Zimmer Biomet for instructions on how to manage the recalled devices. No specific instructions for consumers are provided in the source text, but affected individuals should consult their healthcare provider regarding the recall.
The recalled product
- Product
- Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 360 mm, Item Number: 814309360
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 5,947
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 (1)
- 050830 052950 417420
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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