2.0/2.4 Cannulated Screw Countersink Part # 210-24-002 NON-STERILE and 3.0/4.0 Cannulated Screw C...
FDA Device Recall #Z-2421-2015 — Class II — July 20, 2015
Recall Summary
| Recall Number | Z-2421-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 20, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Trilliant Surgical Ltd. |
| Location | Houston, TX |
| Product Type | Devices |
| Quantity | 102 units |
Product Description
2.0/2.4 Cannulated Screw Countersink Part # 210-24-002 NON-STERILE and 3.0/4.0 Cannulated Screw Countersink Part # 210-40-002 NON-STERILE Product Usage: The Tiger Cannulated Screw Fixation System implants are intended for fixation of fractures, non-unions, arthrodesis, and osteotomies of the small bones in the hand and foot. The implants and guide wires are intended for single use only.
Reason for Recall
The cutting efficiency of the Countersinks was out of specification.
Distribution Pattern
US Nationwide Distribution in the states of: NY, CT, TN, TX, OH, IN, LA, NC, MO, MN, GA, FL, SC, WA, WI, IA, PA, CA, ND, OK, NJ, MI and MD.
Lot / Code Information
Lot numbers 1362-01 and 1364-01
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-2490-2015 | Class II | 7 Hole VL Gridlock Fibula Plate, Part # 300-60-... | Aug 6, 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.