# FDA recall Z-1234-2018

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

## Product

ACE Trochanteric Nail System  ATN LAG SCREW 60MM STERILE  ATN LAG SCREW 65MM STERILE  ATN LAG SCREW 70MM STERILE  ATN LAG SCREW 75MM STERILE  ATN LAG SCREW 80MM STERILE  ATN LAG SCREW 85MM STERILE  ATN LAG SCREW 90MM STERILE  ATN LAG SCREW 95MM STERILE  ATN LAG SCREW 100MM STERILE  ATN LAG SCREW 105MM STERILE  ATN LAG SCREW 110MM STERILE  ATN LAG SCREW 115MM STERILE  ATN LAG SCREW 120MM STERILE  ATN LAG SCREW 125MM STERILE  ATN LAG SCREW 130MM STERILE        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 nonunio

## 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-1234-2018
- **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-1234-2018

## Citation

> AI Analytics. FDA recall Z-1234-2018. Retrieved 2026-05-29 from https://api.ai-analytics.org/recall/Z-1234-2018. Source: US FDA. Licensed CC0.

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