# FDA recall Z-1214-2019

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

## Product

TriMed Hex Cortical Screw 4.0, 40 mm, REF HEX4.0-40, non-Sterile, RX, a component of the TriMed Ankle Fixation System.     The HEX4.0 40 bone screw is a component of the TriMed Ankle Fixation System. The HEX4.0-40 Screw is a single piece machined cortical bone screw. The HEX4.0-40 screw is employed in combination with a TriMed Ankle Bone Plate such as a Sidewinder Plate, Ankle Hook Plate, Cluster, Semi-Tubular Plate, or the Locking Plate. Use of these implants is not a substitute for normal tissue healing. The TriMed Ankle Bone Plates and Screws are designed to provide additional constraint of movement of a fractured bone and are intended only as an aid to fix the fracture in place during the healing process.

## Reason for recall

The bone screw is shorter than the intended design specification.

## Distribution

US Distribution to states of FL and MO.

## Key facts

- **Recall number:** Z-1214-2019
- **Recalling firm:** TriMed Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-08-24
- **Report date:** 2019-05-01
- **Termination date:** 2020-12-28

- **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-1214-2019

## Citation

> AI Analytics. FDA recall Z-1214-2019. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1214-2019. Source: US FDA. Licensed CC0.

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