Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Set Screw Defect
Zimmer Biomet is recalling 2,163 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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving significant injury or structural defects in medical devices are categorized as Severe.
Plain-English summary
Zimmer Biomet, Inc. is recalling 2,163 units of the Affixus Hip Fracture Nail Left 125 Deg 11x300mm (Item Number 814411300). The recall is due to a defect where the set screw is unable to advance or reverse from its original position within the nail. The Affixus Hip Fracture Nail System is an intramedullary hip screw used by surgeons to stabilize fractures of the proximal femur.
The affected devices are distributed nationwide in the United States and in foreign countries including Chile, Costa Rica, Ecuador, and the Netherlands. The specific lot number for the recalled items is 133240 971270.
Healthcare providers and patients should contact Zimmer Biomet for instructions on how to proceed with the recall. The U.S. Food and Drug Administration has classified this as a Class II recall.
The recalled product
- Product
- Affixus Hip Fracture Nail Left 125 Deg 11x300mm, Item Number 814411300 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 2,163
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)
- Lot number 133240 971270
Distribution
Part of a larger recall action
This product is one of 8 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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