Synthes Soft Tissue Retractor Small Extendible Offset blade facilitates easy preparation of th...
FDA Device Recall #Z-0341-2014 — Class II — September 24, 2013
Recall Summary
| Recall Number | Z-0341-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 24, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Synthes USA HQ, Inc. |
| Location | West Chester, PA |
| Product Type | Devices |
| Quantity | 374 |
Product Description
Synthes Soft Tissue Retractor Small Extendible Offset blade facilitates easy preparation of the epipereosteal cavity for percutaneous plate insertion.
Reason for Recall
The potential exists for the locking screw nut to break on the Soft Tissue Retractor if it is overt-tightened.
Distribution Pattern
Worldwide Distribution - USA (Nationwide) and Canada.
Lot / Code Information
Part # Lot # 325.01 1776332 325.01 1834589 325.01 1855361 325.01 1893067 325.01 1903596 325.01 1952258 325.01 1986932 325.01 3067805 325.01 3150691 325.01 3179456 325.01 3186865 325.01 3220973 325.01 3241083 325.01 3268079 325.01 3360992 325.01 3719234 325.01 3818913 325.01 4948929 325.01 4994679 325.01 4994680 325.01 5031083 325.01 5031085 325.01 5391773 325.01 5420979 325.01 5420980 325.01 5476369 325.01 5476370 325.01 5510070 325.01 5544585 325.01 5546329 325.01 5563699 325.01 5569041 325.01 5624246 325.01 5657366 325.01 5677289 325.01 5759764 325.01 5759765 325.01 5779363 325.01 7698954 325.01 7826103
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-0394-2014 | Class II | Synthes Spiked Washers 13.5/6.5 Spiked Washe... | Oct 3, 2013 |
| Z-0369-2014 | Class II | Synthes Titanium Trochanteric Fixation Nail (TF... | 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.