# FDA recall Z-0604-2018

> **Synthes (USA) Products LLC** · Class II · device recall initiated 2017-07-21.

## Product

11MM/130 Degree Titanium Trochanteric Fixation Nail 380MM/Right, Sterile

## Reason for recall

The locking mechanism and protective cap were missing from the sterile packed nails of the affected lot.

## Distribution

TX, GA, PA, UT and Canada

## Key facts

- **Recall number:** Z-0604-2018
- **Recalling firm:** Synthes (USA) Products LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-07-21
- **Report date:** 2018-02-21
- **Termination date:** 2018-07-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** West Chester, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0604-2018

## Citation

> AI Analytics. FDA recall Z-0604-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0604-2018. Source: US FDA. Licensed CC0.

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