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 to meet clinical survivorship criteria.
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 involves a high-risk orthopedic implant where a performance failure (survivorship) was identified, but no specific injuries or illnesses are reported in the source text, fitting the 'High' criteria for risk-of-harm products without reported injury.
Plain-English summary
Zimmer Biomet, Inc. is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system. The recall involves 3,454 units of the STER TROC NAIL 125 DEG X 9MM, STER TROC NAIL 130 DEG X 9MM, and STER TROC NAIL 135 DEG X 9MM, identified by codes 903209125, 903209130, and 903209135. These devices are intended to treat stable and unstable proximal fractures of the femur, including pertrochanteric and intertrochanteric fractures.
The recall was initiated after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the acceptance criteria for the DPR protocol for the ATN system. The source text does not specify reported injuries, illnesses, or specific distribution dates beyond the nationwide distribution in the USA.
Healthcare providers and patients should contact Zimmer Biomet for further instructions regarding the recall and potential replacement or repair of the affected devices.
The recalled product
- Product
- ACE Trochanteric Nail System STER TROC NAIL 125 DEG X 9MM STER TROC NAIL 130 DEG X 9MM STER TROC NAIL 135 DEG X 9MM The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric f
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- 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)
- 903209125 903209130 903209135
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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