Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Defect
Zimmer Biomet is recalling 5,947 Affixus Hip Fracture Nail 125 units 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 failure of a medical implant component. No injuries or illnesses are reported in the source text, placing this in the 'High' category per the rubric 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 125, 11 mm x 180 mm (Item Number: 814311180). The recall is due to a defect where the set screw is unable to advance or reverse from its original position within the nail.
The affected products were distributed to 41 US states and Puerto Rico, as well as to Chile, Ecuador, Japan, and the Netherlands. The recall covers specific lot codes listed in the agency's records.
This is a Class II recall, meaning there is a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences. Healthcare providers and patients should contact Zimmer Biomet for instructions on how to proceed with the affected devices.
The recalled product
- Product
- Affixus¿ Hip Fracture Nail 125¿ 11 mm x 180 mm, Item Number: 814311180
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 5,947
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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