Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER Synthes 4.5MM TI VA-LCP CRVD Condyl...
FDA Device Recall #Z-0401-2014 — Class II — May 29, 2013
Recall Summary
| Recall Number | Z-0401-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 29, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Synthes USA HQ, Inc. |
| Location | West Chester, PA |
| Product Type | Devices |
| Quantity | 1 |
Product Description
Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER is used for buttressing multi fragmentary diatal femur fractures including: supra-condylar, intra-articular and extra articular condylar fractures, periprosthetic fractures, fractures in normal or osteopenic bone, nonunions and malunions.
Reason for Recall
A plate was inadvertently released to a sales consultant that was restricted for sale.
Distribution Pattern
US Distribution in Colorado.
Lot / Code Information
part 04.124.406S, lot 3771678.
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.