# FDA recall Z-0359-2020

> **TriMed Inc.** · Class II · device recall initiated 2018-09-28.

## Product

TriMed Wrist Hook Dorsal Impactor, REF IMPCT-WHD; and TriMed Wrist Hook Volar Impactor, REF IMPCT-WHV, both nonsterile, Rx,  The firm name on the labels is TriMed Inc., Santa Clarita, CA.

## Reason for recall

The WHD/WHV impactors can rust over time due to an improper manufacturing process.

## Distribution

Distribution was nationwide.  There was military distribution but no government distribution.  Foreign distribution was made to Australia, China, South Africa, and Sweden.

## Key facts

- **Recall number:** Z-0359-2020
- **Recalling firm:** TriMed Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2018-09-28
- **Report date:** 2019-11-20

- **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-0359-2020

## Citation

> AI Analytics. FDA recall Z-0359-2020. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-0359-2020. Source: US FDA. Licensed CC0.

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