# FDA recall Z-0118-2020

> **TriMed Inc.** · Class II · device recall initiated 2018-08-24.

## Product

TriMed Dorsal Wrist Hook Plate, Dorsal, 4-Hole, REF WHD-4, contained in a tray, insert, or poly package containing varying amounts, Nonsterile, Single Use Only, Rx.  The firm name on the label is TriMed, Santa Clarita, CA.

## Reason for recall

Modifications to the specification were not appropriately qualified through the company's design control process which may result in structural integrity issues of the device.

## Distribution

Distribution was made to CA, FL, MD, TX, and WA.  There was military and foreign distribution was made to Australia.  There was no government distribution.

## Key facts

- **Recall number:** Z-0118-2020
- **Recalling firm:** TriMed Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-08-24
- **Report date:** 2019-10-16
- **Termination date:** 2021-04-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Santa Clarita, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0118-2020

## Citation

> AI Analytics. FDA recall Z-0118-2020. Retrieved 2026-07-07 from https://api.ai-analytics.org/recall/Z-0118-2020. Source: US FDA. Licensed CC0.

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