Synthes Tensioning Device The Synthes Osteogenesis System, MR Conditional is intended for fra...

FDA Device Recall #Z-0388-2014 — Class II — July 31, 2013

Recall Summary

Recall Number Z-0388-2014
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 369

Product Description

Synthes Tensioning Device The Synthes Osteogenesis System, MR Conditional is intended for fracture fixation (open and closed), pseudoarthrosis or non-unions of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformities and correction of segmental bony or soft tissue defects in adult and pediatric patients.

Reason for Recall

All lots of the Synthes Tensioning Device were recalled due to the potential for the reaction fork to come loose from the main body of the device and not allow the wire to release, nor the device to apply tension.

Distribution Pattern

Nationwide Distribution.

Lot / Code Information

all lots of model number 03.311.001: Part # Synthes lot # 03.311.001 1934765 03.311.001 1934766 03.311.001 1993844 03.311.001 3036688 03.311.001 3398576 03.311.001 3776484 03.311.001 5100597 03.311.001 5106354 03.311.001 5160872 03.311.001 5160875 03.311.001 5174253 03.311.001 5174253 03.311.001 5174254 03.311.001 5181000 03.311.001 5181001 03.311.001 5196282 03.311.001 5196283 03.311.001 5197081 03.311.001 5241942 03.311.001 5241943 03.311.001 5336723 03.311.001 5363637 03.311.001 5396016 03.311.001 5411479 03.311.001 5555521

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.