# FDA recall Z-1226-2018

> **Zimmer Biomet, Inc.** · Class II · device recall initiated 2017-12-20.

## 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 including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail System is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal nonunions and malunions and revision procedures.

## Reason for recall

Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the acceptance criteria for the DPR protocol for the ATN system.

## Distribution

USA (nationwide)

## Key facts

- **Recall number:** Z-1226-2018
- **Recalling firm:** Zimmer Biomet, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-12-20
- **Report date:** 2018-04-04
- **Termination date:** 2020-04-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Warsaw, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1226-2018

## Citation

> AI Analytics. FDA recall Z-1226-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1226-2018. Source: US FDA. Licensed CC0.

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