Zimmer Biomet Recalls Affixus Hip Fracture Nail 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.
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 involves a structural defect in a high-risk medical device (hip fracture nail) where the set screw fails to function. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported, and it does not meet the criteria for Severe (4) which requires hospitalization reports or structural vehicle defects.
Plain-English summary
Zimmer Biomet, Inc. is recalling 5,947 units of the Affixus Hip Fracture Nail Left 125° 9 mm x 400 mm (Item Number: 814409400). The recall was initiated because the set screw is not able to advance or reverse from the original position in 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 specific lot codes associated with this recall are 051130, 053810, 133200, 153200, 813940, 097150, and 767720.
Healthcare providers and patients should contact Zimmer Biomet for further instructions regarding the replacement or return of these devices. The source text does not report any specific injuries or illnesses associated with this defect.
The recalled product
- Product
- Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 400 mm, Item Number: 814409400
- Manufacturer
- Zimmer Biomet, Inc.
- 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)
- 051130 053810 133200 153200 813940 097150 767720
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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