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
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls with potential for significant injury or adverse health consequences are rated as Severe (4).
Plain-English summary
Zimmer Biomet, Inc. is recalling 5,947 units of the Affixus Hip Fracture Nail Right 125 13 mm x 400 mm (Item Number: 814313400). The recall is due to a defect where the set screw is unable to advance or reverse from the original position in the nail.
The affected products were distributed to numerous US states, including Alabama, Arizona, California, Florida, New York, and Texas, as well as Puerto Rico. The products were also distributed to foreign countries including Chile, Ecuador, Japan, and the Netherlands.
This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. Healthcare providers and patients should contact Zimmer Biomet for further instructions regarding the affected devices.
The recalled product
- Product
- Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 400 mm, Item Number: 814313400
- 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)
- 501350
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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