# FDA recall Z-0366-2020

> **TriMed Inc.** · Class II · device recall initiated 2018-08-15.

## Product

TriMed Olecranon Hook Plate, Lt, 6-Holes, REF: OHOOKL-6, Non-Sterile, RX only,  (01) 00842188101281 - Product Usage: The OHOOKL is a semi-tubular design bone plate with two offset intramedullary tines, which are intended to penetrate the small terminal fragment to provide additional stabilization.

## Reason for recall

The firm has become aware that the angled-hole of certain semi-tubular design bone plates may have been modified from its specification, and the modification may not have been fully qualified.

## Distribution

US Nationwide distribution in the states of MD, UT.

## Key facts

- **Recall number:** Z-0366-2020
- **Recalling firm:** TriMed Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-08-15
- **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-0366-2020

## Citation

> AI Analytics. FDA recall Z-0366-2020. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/Z-0366-2020. Source: US FDA. Licensed CC0.

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