2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM Fixation of fractures, oste...
FDA Device Recall #Z-0380-2014 — Class II — July 31, 2013
Recall Summary
| Recall Number | Z-0380-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 31, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Synthes USA HQ, Inc. |
| Location | West Chester, PA |
| Product Type | Devices |
| Quantity | 98 |
Product Description
2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM Fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone.
Reason for Recall
Specific lots of the SS 2.4mm and SS 2.7mm Locking Screw (self-tapping) due to a mislabeling issue. The SS 2.7mm Screw was labeled as SS 2.4 mm Screw.
Distribution Pattern
Nationwide Distribution including PA, CA, FL, MO, KS, IN, IL, WV, KY, LA, NM, SC, IA, TX, AZ, GA, NC, OK, NY, TN, MI, CO, and MT.
Lot / Code Information
Lot 3420620
Other Recalls from Synthes USA HQ, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0393-2014 | Class II | Synthes Material Mix (Adjustable Cervical Distr... | Oct 15, 2013 |
| Z-0473-2014 | Class II | Synthes TomoFix Plates The Synthes J5606-C T... | Oct 9, 2013 |
| Z-0405-2014 | Class II | Synthes Implant Holder for Synfix (TM)-LR th... | Oct 8, 2013 |
| Z-0369-2014 | Class II | Synthes Titanium Trochanteric Fixation Nail (TF... | Oct 3, 2013 |
| Z-0394-2014 | Class II | Synthes Spiked Washers 13.5/6.5 Spiked Washe... | Oct 3, 2013 |
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.