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.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as a Class II recall. Per the rubric, FDA Class II recalls involving significant injury or structural defects in medical devices are categorized as Severe (Score 4).
Plain-English summary
Zimmer Biomet, Inc. is recalling the Affixus Hip Fracture Nail Left 130° 13 mm x 400 mm (Item Number: 814613400). The recall involves 5,947 units of the medical device.
The recall was initiated because the set screw is not able to advance or reverse from the original position in the nail. This functional defect may affect the device's performance during or after surgical implantation.
The affected products were distributed to 38 US states and Puerto Rico, as well as to Chile, Ecuador, Japan, and the Netherlands. Healthcare providers and patients who have received this specific device should contact Zimmer Biomet for further instructions regarding the recall.
The recalled product
- Product
- Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 400 mm, Item Number: 814613400
- 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)
- 055730 060770 154510 558410 712370 543380
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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Similar recalls
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