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.