Zimmer Biomet Recalls ACE Trochanteric Nail System Due to Performance Failure
Zimmer Biomet is recalling the ACE Trochanteric Nail System because 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 source text does not report any hospitalizations, injuries, or deaths, and the hazard is a performance failure (survivorship) rather than a high-risk pathogen or structural defect with reported harm, placing it in the High category per the rubric.
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 system, which is 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 affected product codes are 903213125, 903213130, and 903213135.
The recall is classified as Class II by the FDA. The distribution pattern is listed as USA (nationwide). The source text does not specify specific actions for consumers or patients, nor does it report any specific injuries or illnesses associated with the device.
The recalled product
- Product
- ACE Trochanteric Nail System TROCH NAIL ST 13X180 125DG STRL TROCH NAIL ST 13X180 130DG STRL TROCH NAIL ST 13X180 135DG STRL The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertroch
- 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)
- 903213125 903213130 903213135
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.
See all 11 products in this recall →Related recalls
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Same hazard · device performance failure
See all →- HighZimmer Biomet Recalls ACE Trochanteric Nail System Due to Performance Failure
FDA (Devices) · 2018-04-04