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.
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 structural defect in a medical device used for fracture stabilization. While no injuries or illnesses are reported in the source text, the risk of harm from a device that cannot function as intended during surgery places this in the 'High' category per the rubric 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 Left 125 Deg 9x165mm (Item Number 816709165). The recall covers specific lot numbers: 063610, 063630, and 816520. 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 functional defect may prevent proper surgical fixation of the hip fracture.
The affected devices were distributed nationwide in the United States to 43 states and Puerto Rico, as well as to Chile, Costa Rica, Ecuador, and the Netherlands. Healthcare providers and facilities that have received these specific lot numbers should stop using them and contact Zimmer Biomet for instructions on return or replacement.
The recalled product
- Product
- Affixus Hip Fracture Nail Left 125 Deg 9x165mm, Item Number 816709165 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.
- 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 063610 063630 816520
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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