Zimmer Biomet Recalls ACE Trochanteric Nail System Due to Performance Failure
Zimmer Biomet is recalling the ACE Trochanteric Nail System after a Device Performance Review failed clinical analysis for survivorship.
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 failure in clinical analysis for survivorship of an orthopedic implant, which poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Zimmer Biomet, Inc. is conducting a Class II medical device recall for the ACE Trochanteric Nail (ATN) system. The recall involves specific sterile trochanteric nail components, including models with 125, 130, and 135-degree angles and 11mm diameter, as well as the 180x11x140 model. The product is intended to treat stable and unstable proximal fractures of the femur, including pertrochanteric, intertrochanteric, and high subtrochanteric fractures.
The recall was initiated after a Device Performance Review (DPR) failed the clinical analysis for survivorship pursuant to the acceptance criteria for the DPR protocol for the ATN system. The source text does not specify the number of affected units, the distribution scope, or any reported injuries or illnesses associated with the device.
Healthcare providers and patients who have received this device should contact Zimmer Biomet for further instructions on the recall and potential replacement or repair options. The source text does not provide specific contact information or a deadline for action.
The recalled product
- Product
- ACE Trochanteric Nail System STER TROC NAIL 180X11X140 STER TROC NAIL 125 DEG X 11MM STER TROC NAIL 130 DEG X 11MM STER TROC NAIL 135 DEG X 11MM The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 3,454
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)
- 903211140 903211225 903211230 903211235
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 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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