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.
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, and the defect involves a structural failure of a load-bearing orthopedic implant, which poses a significant risk of injury.
Plain-English summary
Zimmer Biomet, Inc. is recalling 5,947 units of the Affixus Hip Fracture Nail Right 130° 11 mm x 400 mm (Item Number: 814511400). 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 38 US states and Puerto Rico, as well as to Chile, Ecuador, Japan, and the Netherlands. The specific lot codes associated with this recall are 054240, 054250, 154980, 472860, 773390, 798600, 798610, 017490, and 245530.
Healthcare providers and facilities that have received these devices should contact Zimmer Biomet for instructions on how to return or replace the affected units. Patients who have had this specific device implanted should consult their healthcare provider to discuss the potential implications of the defect.
The recalled product
- Product
- Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 400 mm, Item Number: 814511400
- 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)
- 054240 054250 154980 472860 773390 798600 798610 017490 245530
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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