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 is classified as FDA Class II. The hazard involves a mechanical failure of a medical device used for fracture stabilization, which presents a risk of harm, but the source text does not report specific injuries or illnesses.
Plain-English summary
Zimmer Biomet, Inc. is recalling the Affixus Hip Fracture Nail 130 Deg 10x165mm (Item Number 816810165). The Affixus Hip Fracture Nail System is an intramedullary hip screw used by surgeons to stabilize fractures of the proximal femur.
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. This issue affects 2,163 units in total. The affected lots are 558260 and 558270.
The product was distributed nationwide in the United States to specific states and Puerto Rico, as well as to Chile, Costa Rica, Ecuador, and the Netherlands. Healthcare providers and patients should contact Zimmer Biomet for further instructions regarding the recall.
The recalled product
- Product
- Affixus Hip Fracture Nail 130 Deg 10x165mm, Item Number 816810165 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 558260 558270
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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