Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Set Screw Malfunction
Zimmer Biomet is recalling 2,163 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, and the source text describes a mechanical defect in a high-risk medical device without reporting specific injuries or illnesses, 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 2,163 units of the Affixus Hip Fracture Nail 125 Deg 10x165mm (Item Number 816710165). The recall covers Lot numbers 945090 and 945230. The Affixus Hip Fracture Nail System is an intramedullary hip screw used by surgeons to stabilize fractures of the proximal femur.
The recall was initiated because the set screw is not able to advance or reverse from the original position in the nail. This mechanical defect may prevent proper stabilization of the hip fracture during or after surgery.
The affected devices were distributed nationwide in the United States to 41 states and Puerto Rico, as well as to Chile, Costa Rica, Ecuador, and the Netherlands. Healthcare providers and patients who have received or used these specific devices should contact Zimmer Biomet or their local FDA office for further instructions on how to proceed.
The recalled product
- Product
- Affixus Hip Fracture Nail 125 Deg 10x165mm, Item Number 816710165 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 945090 945230
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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