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. Per the rubric, risk-of-harm products where injury has not yet been reported are assigned a score of 3 (High).
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 END CAP components in various sizes (5mm, 10mm, 15mm, 20mm, and 25mm). 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 agency has classified this recall as Class II.
The affected units were distributed nationwide in the USA. The source text does not specify specific lot numbers, expiration dates, or reported injuries or illnesses associated with this recall.
The recalled product
- Product
- ACE Trochanteric Nail System STER TROC END CAP STER TROC END CAP 5MM STER TROC END CAP 10MM STER TROC END CAP 15MM STER TROC END CAP 20MM STER TROC END CAP 25MM The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur includin
- 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)
- 903208000 903208010 903208015 903208020 903208025
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
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