Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Set Screw Defect
Zimmer Biomet is recalling 5,947 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, which typically indicates a risk of temporary or medically reversible adverse health consequences. The defect involves a mechanical failure of a surgical implant component, which poses a significant risk of harm if the device fails during or after surgery, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Zimmer Biomet, Inc. is recalling 5,947 units of the Affixus Hip Fracture Nail Right 130° 11 mm x 340 mm (Item Number: 814511340). 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 40 US states and Puerto Rico, as well as to Chile, Ecuador, Japan, and the Netherlands. The specific lot codes associated with this recall are 054180, 483490, 519590, 558900, 558910, 586640, and 371200.
This is a Class II recall, indicating that use of the product could cause temporary or medically reversible adverse health consequences. Healthcare providers and facilities should contact Zimmer Biomet for instructions on how to manage the affected devices.
The recalled product
- Product
- Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 340 mm, Item Number: 814511340
- 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)
- 054180 483490 519590 558900 558910 586640 371200
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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