Slipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE Screw System with catal...

FDA Device Recall #Z-1848-2015 — Class II — June 15, 2015

Recall Summary

Recall Number Z-1848-2015
Classification Class II — Moderate risk
Date Initiated June 15, 2015
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Pega Medical Inc.
Location Laval
Product Type Devices
Quantity 4 units

Product Description

Slipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE Screw System with catalogue number SCF-MLD265 and SCF-MLD273.

Reason for Recall

SCFE Drivers of the Free-Gliding SCFE Screw System are recalled because the handle of the instruments may detach from the shaft if high torques are applied in counter-clockwise rotation.

Distribution Pattern

US Distribution to the states of : FL and TN.

Lot / Code Information

Part Number: SCF-MLD265, LOT#: 130703-01. Part Number: SCF-MLD273, LOT#: 130703-02.

Other Recalls from Pega Medical Inc.

Recall # Classification Product Date
Z-2038-2020 Class III Orthopedic manual Surgical Instrument handle fo... Apr 3, 2020
Z-0270-2020 Class II SCFE (slipped capital femoral epiphysis) Knobs ... Oct 2, 2019
Z-2278-2019 Class II SLIM Handle - catalogue #: SLM-HND100 a compone... May 29, 2019
Z-0324-2016 Class II SCFE Driver (SCF-MLD273 & SCF-MLD265) instrumen... Oct 20, 2015
Z-1546-2015 Class II Female Driver, Part number FDr101, instrument u... Apr 10, 2015

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.