Slipped Capital Femoral Epiphysis System Product Usage: Intended for fracture fixation of la...

FDA Device Recall #Z-0408-2014 — Class II — July 31, 2013

Recall Summary

Recall Number Z-0408-2014
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 166

Product Description

Slipped Capital Femoral Epiphysis System Product Usage: Intended for fracture fixation of large bones and large bone fragments and for slipped capital femoral epiphysis, pediatric femoral neck fractures, intercondylar femur fractures and sacroiliac joint disruptions.

Reason for Recall

There is a possibility for the Guide Wires of the Slipped Capital Femoral Epiphysis System to stick in the cannulation of the drill bit and the drill bits to break during surgery.

Distribution Pattern

USA Nationwide Distribution

Lot / Code Information

Parts 03.207.001 and 03.207.008 with lot numbers: Part # Lot # 03.207.001 PE00376 PE00439 PE01391 PE01329 PE01412 PE00504 03.207.008 PE00440 PE00377 PE00513 PE01475 PE01691

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.