Synthes Matrix Threaded Persuader Deformity is a comprehensive thoracolumbar pedical screw sys...

FDA Device Recall #Z-0384-2014 — Class II — July 31, 2013

Recall Summary

Recall Number Z-0384-2014
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 634

Product Description

Synthes Matrix Threaded Persuader Deformity is a comprehensive thoracolumbar pedical screw system designed to provide flexibility biomechanical performance and a solution to complex posterior pathological challenges.

Reason for Recall

Synthes became aware that during a procedure using the Matrix Threaded Persuader, the Reduction Insert malfunctioned causing pieces to break off. Once there is a breakage to the Reduction Insert it will not allow the instrument to function as required.

Distribution Pattern

Worldwide distribution: US (nationwide) and countries of Canada and Switzerland.

Lot / Code Information

Item Lot Number Number 03.632.008 4833901 03.632.008 6284014 03.632.008 6284015 03.632.008 6377412 03.632.008 6390270 03.632.008 6390308 03.632.008 6390309 03.632.008 6445711 03.632.008 6455761 03.632.008 6455786 03.632.008 6530998 03.632.008 6548747 03.632.008 6558995 03.632.008 6559002 03.632.008 6583188 03.632.008 6583189 03.632.008 6603334 03.632.008 6603335 03.632.008 6624550 03.632.008 6676663 03.632.008 6703414 03.632.008 6706733 03.632.008 6718634 03.632.008 6718635 03.632.008 4833901 03.632.008 6445711 03.632.008 6455761 03.632.008 6455786 03.632.008 6530998 03.632.008 6548747 03.632.008 6603334 03.632.008 6603335 03.632.008 6676663 03.632.008 6703414 03.632.008 6706733 03.632.008 6718634 03.632.008 6718635

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.