TriMed Hex Driver 1.2, 55mm AO Cannulated, REF HXDRIVR-1.2C AO, nonsterile, Rx. The firm name on...

FDA Device Recall #Z-0357-2020 — Class II — September 28, 2018

Recall Summary

Recall Number Z-0357-2020
Classification Class II — Moderate risk
Date Initiated September 28, 2018
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm TriMed Inc.
Location Santa Clarita, CA
Product Type Devices
Quantity 467 hex drivers

Product Description

TriMed Hex Driver 1.2, 55mm AO Cannulated, REF HXDRIVR-1.2C AO, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.

Reason for Recall

The epoxy on Apex manufactured epoxy-coated instruments can pop off.

Distribution Pattern

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

Lot / Code Information

Lot numbers 91500604 and 91600017

Other Recalls from TriMed Inc.

Recall # Classification Product Date
Z-1792-2024 Class II TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: ... Mar 19, 2024
Z-1791-2024 Class II TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: ... Mar 19, 2024
Z-0932-2024 Class II Volar Bearing Plate. REF: VBEAL-3-7N, VBEAL... Nov 28, 2023
Z-1101-2023 Class II RipCord Syndesmosis Button, REF: STA001K Dec 22, 2022
Z-0359-2020 Class II TriMed Wrist Hook Dorsal Impactor, REF IMPCT-WH... Sep 28, 2018

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.