TriMed Olecranon Hook Plate, Lt, 6-Holes, REF: OHOOKL-6, Non-Sterile, RX only, (01) 008421881012...

FDA Device Recall #Z-0366-2020 — Class II — August 15, 2018

Recall Summary

Recall Number Z-0366-2020
Classification Class II — Moderate risk
Date Initiated August 15, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm TriMed Inc.
Location Santa Clarita, CA
Product Type Devices
Quantity 583 Bone Plates

Product Description

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 Pattern

US Nationwide distribution in the states of MD, UT.

Lot / Code Information

Lot # 110631,

Other Recalls from TriMed Inc.

Recall # Classification Product Date
Z-1791-2024 Class II TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: ... Mar 19, 2024
Z-1792-2024 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-0357-2020 Class II TriMed Hex Driver 1.2, 55mm AO Cannulated, REF ... 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.