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: The recall is classified as FDA Class II, and the source describes a functional defect in a high-risk medical device without reporting specific injuries or illnesses, aligning with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zimmer Biomet, Inc. is recalling the Affixus Hip Fracture Nail Left 125° 11 mm x 400 mm (Item Number: 814411400). The recall involves 5,947 units of the medical device.
The recall was initiated because the set screw is not able to advance or reverse from the original position in the nail. This functional defect may impact the intended use of the device.
The products were distributed to 41 US states and Puerto Rico, as well as to Chile, Ecuador, Japan, and the Netherlands. Affected lot codes include 053980, 053990, 646590, 768010, 530100, and 646600. Healthcare providers and patients should contact Zimmer Biomet for further instructions regarding the recall.
The recalled product
- Product
- Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 400 mm, Item Number: 814411400
- 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)
- 053980 053990 646590 768010 530100 646600
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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