Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medullary (SLIM) System - P...
FDA Device Recall #Z-2038-2020 — Class III — April 3, 2020
Recall Summary
| Recall Number | Z-2038-2020 |
| Classification | Class III — Low risk |
| Date Initiated | April 3, 2020 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Pega Medical Inc. |
| Location | Laval, N/A |
| Product Type | Devices |
| Quantity | 3 units |
Product Description
Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medullary (SLIM) System - Product Usage: The SLIM handle is the grip for the SLIM driver in orthopedic surgical procedures.
Reason for Recall
The lot number on the pediatric orthopedic implant driver instrument handle does not match the lot number on the label.
Distribution Pattern
US Nationwide Distribution including in the states of Florida. No Foreign Consignees listed.
Lot / Code Information
SLIM Handle with Catalog #SLM-HND100 with etched lot code #B204-1 on the handle and with Lot# B204-01 on the packaging label.
Other Recalls from Pega Medical Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| 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-1848-2015 | Class II | Slipped Capital Femoral Epiphysis (SCFE) Driver... | Jun 15, 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.