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
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a 'Severe' severity score under the rubric, particularly given the potential for significant injury associated with orthopedic implant failures.
Plain-English summary
Zimmer Biomet, Inc. is recalling 5,947 units of the Affixus Hip Fracture Nail Right 125° 9 mm x 320 mm (Item Number: 814309320). The recall is due to a defect where the set screw is not able to advance or reverse from the original position in the nail.
The affected products were distributed to 38 US states and Puerto Rico, as well as to Chile, Ecuador, Japan, and the Netherlands. The specific code information for the recalled items is 789980.
This is an FDA Class II recall. Healthcare providers and patients should contact Zimmer Biomet for further instructions regarding the replacement or return of these devices.
The recalled product
- Product
- Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 320 mm, Item Number: 814309320
- 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)
- 789980
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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