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. The defect involves a mechanical failure of a surgical implant component (set screw) which poses a risk of harm, but the source text does not report specific injuries or hospitalizations, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zimmer Biomet, Inc. is recalling 5,947 units of the Affixus Hip Fracture Nail Right 125 13 mm x 460 mm (Item Number: 814313460). 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 38 U.S. states and Puerto Rico, as well as to Chile, Ecuador, Japan, and the Netherlands. The specific codes associated with the recall are 083760 and 017310.
Healthcare providers and patients should contact Zimmer Biomet for instructions on how to proceed with the recall. This recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 460 mm, Item Number: 814313460
- 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)
- 083760 017310
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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