Synthes TomoFix Plates The Synthes J5606-C TomoFix Osteotomy System is used for open and close...

FDA Device Recall #Z-0473-2014 — Class II — October 9, 2013

Recall Summary

Recall Number Z-0473-2014
Classification Class II — Moderate risk
Date Initiated October 9, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Synthes USA HQ, Inc.
Location West Chester, PA
Product Type Devices
Quantity 2912

Product Description

Synthes TomoFix Plates The Synthes J5606-C TomoFix Osteotomy System is used for open and closed wedge osteotomies of the medial proximal tibia, lateral proximal tibia, medial and lateral distal femur, treatment of bone and joint deformities, fractures, and malalignment caused by injury or disease such as osteoarthritis.

Reason for Recall

A labeling correction was initiated related to the Surgical Technique Guide J5606-C "TomoFix Osteotomy System" due to the potential for a surgical delay if the surgeon inserts the superior screws at a lesser angle (4 or 6 degrees) and is not aware that those angles are not present.

Distribution Pattern

Worldwide Distribution - USA (nationwide) Canada and Mexico

Lot / Code Information

J5606-C

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-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
Z-0202-2014 Class II Synthes 8.5 MM Medullary Reamer Product Usa... 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.