Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Malfunction
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: This is a Class II recall for a medical device with a functional defect that poses a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Zimmer Biomet, Inc. is recalling 5,947 units of the Affixus Hip Fracture Nail Right 125° 11 mm x 340 mm (Item Number: 814311340). 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 numerous US states, including Alabama, Arizona, California, Florida, New York, and Texas, as well as Puerto Rico. The products were also distributed to Chile, Ecuador, Japan, and the Netherlands. The specific lot codes associated with this recall are 152960, 331460, 456050, and 944450.
Healthcare providers and facilities should check their inventory for this specific item number and lot codes. If the product is found, it should be removed from use and returned to Zimmer Biomet, Inc. according to the company's instructions.
The recalled product
- Product
- Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 340 mm, Item Number: 814311340
- 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)
- 152960 331460 456050 944450
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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