7 Hole VL Gridlock Fibula Plate, Part # 300-60-001 NON-STERILE SINGLE USE ONLY; 9 Hole VL Gridloc...
FDA Device Recall #Z-2490-2015 — Class II — August 6, 2015
Recall Summary
| Recall Number | Z-2490-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 6, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Trilliant Surgical Ltd. |
| Location | Houston, TX |
| Product Type | Devices |
| Quantity | 28 units |
Product Description
7 Hole VL Gridlock Fibula Plate, Part # 300-60-001 NON-STERILE SINGLE USE ONLY; 9 Hole VL Gridlock Fibula Plate, Part # 300-60-002 NON-STERILE SINGLE USE ONLY; 11 Hole VL Gridlock Fibula Plate, Part # 300-60-003 NON-STERILE SINGLE USE ONLY. For use in trauma and reconstructive procedures in small bones.
Reason for Recall
The affected parts subject to the recall are out of specification, resulting in in the loss of the optimal locking screw functionality of the plates. The thread depth of the screw holes is insufficient, potentially limiting the ability to engage and lock with associated mating locking screws.
Distribution Pattern
US Distribution to the states of : FL, OH, NJ, MN, WI, NM and CA.
Lot / Code Information
Lots: TSL002595, TSL002596, TSL002597
Other Recalls from Trilliant Surgical Ltd.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2339-2018 | Class II | Ratcheting Cannulated Driver Handle, Catalog #:... | Mar 27, 2018 |
| Z-2338-2018 | Class II | Cannulated Driver Handle, Catalog #: 210-00-003... | Mar 27, 2018 |
| Z-0960-2017 | Class II | Tiger Screw Sterilization Tray Base Assembly Mo... | Dec 8, 2016 |
| Z-0609-2017 | Class II | Model 208-70-110, Long Thread Tiger Large Cannu... | Sep 2, 2016 |
| Z-2738-2015 | Class II | 2.4, 3.0, and 4.0 mm Gridlock Screw Driver Bit,... | Jul 31, 2015 |
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.