# FDA recall Z-1235-2018

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

## Product

ACE Trochanteric Nail System  STER L H TROC NAIL 320X9X125  STER L H TROC NAIL 340X9X125  STER L H TROC NAIL 360X9X125  STER L H TROC NAIL 380X9X125  STER L H TROC NAIL 400X9X125  STER L H TROC NAIL 420X9X125  STER L H TROC NAIL 440X9X125  STER L H TROC NAIL 460X9X125  STER L H TROC NAIL 320X11X125  STER L H TROC NAIL 340X11X125  STER L H TROC NAIL 360X11X125  STER L H TROC NAIL 380X11X125  STER L H TROC NAIL 400X11X125  STER L H TROC NAIL 420X11X125  STER L H TROC NAIL 440X11X125  STER L H TROC NAIL 460X11X125  STER L H TROC NAIL 320X13X125  STER L H TROC NAIL 340X13X125  STER L H TROC NAIL 360X13X125  STER L H TROC NAIL 380X13X125  STER L H TROC NAIL 400X13X125  STER L H TROC NAIL 420X13X125  STER L H TROC NAIL 440X13X125  STER L H TROC NAIL 460X13X125  STER R H TROC NAIL 320X9X125  STER R H TROC NAIL 340X9X125  STER R H TROC NAIL 360X9X125  STER R H TROC NAIL 380X9X125  STER R H TROC NAIL 400X9X125  STER R H TROC NAIL 420X9X125  STER R H TROC NAIL 440X9X125  STER R H TROC NAIL 460X9

## 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-1235-2018
- **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-1235-2018

## Citation

> AI Analytics. FDA recall Z-1235-2018. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1235-2018. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*