Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Issue
Zimmer Biomet is recalling Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 functional failure of a medical device where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Zimmer Biomet, Inc. is recalling the Affixus Hip Fracture Nail Right 125° 11 mm x 440 mm (Item Number: 814311440). The recall involves 5,947 units of the device.
The recall was initiated because the set screw is not able to advance or reverse from the original position in the nail. This defect may affect the functionality of the medical device.
The products were distributed to 38 US states and Puerto Rico, as well as Chile, Ecuador, Japan, and the Netherlands. Affected lot codes include 050850, 155250, 500840, 541270, and 559240. Healthcare providers should contact Zimmer Biomet for instructions on how to handle the recalled devices.
The recalled product
- Product
- Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 440 mm, Item Number: 814311440
- 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)
- 050850 155250 500840 541270 559240
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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