Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Defect
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 involves a high-risk medical device with a functional defect that could compromise the stability of a hip fracture fixation. No injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zimmer Biomet, Inc. is recalling 5,947 units of the Affixus Hip Fracture Nail Right 130° 9 mm x 440 mm (Item Number: 814509440). 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 lot codes associated with this recall are 054150, 054170, 130740, 130750, 188310, 519480, 472970, and 503970.
Healthcare providers and facilities should contact Zimmer Biomet for instructions on how to manage the affected devices. Consumers should not use the recalled product and should contact their healthcare provider if they have questions regarding their implant.
The recalled product
- Product
- Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 440 mm, Item Number: 814509440
- 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)
- 054150 054170 130740 130750 188310 519480 472970 503970
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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