BASE, S-LIFT Instrument Case Product Usage: System cases are designed to hold and secure all...
FDA Device Recall #Z-1664-2013 — Class II — May 17, 2013
Recall Summary
| Recall Number | Z-1664-2013 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 17, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | SpineFrontier, Inc. |
| Location | Beverly, MA |
| Product Type | Devices |
| Quantity | 12 |
Product Description
BASE, S-LIFT Instrument Case Product Usage: System cases are designed to hold and secure all instrumentation to be used with a surgical system. Case and caddy components are used to contain implants intended for intervertebral body fusion and fixation of the spine.
Reason for Recall
The S-LIFT Instrument Case contained a bracket with peeling nylon coating.
Distribution Pattern
USA Nationwide including the states of: FL, CO, Wash DC, VA, KS, TX, OH, TN, OK, CA, IL, MO, and MN.
Lot / Code Information
Lot/Serial Numbers: 7201.007 and 7201.007-1
Other Recalls from SpineFrontier, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1973-2019 | Class II | A-CIFT SoloFuse Fixed Angle Driver, Model Numbe... | Jun 13, 2019 |
| Z-1479-2015 | Class II | SpineFrontier MISquito Percutaneous Pedicle S... | Mar 5, 2015 |
| Z-0977-2015 | Class II | lnline Persuader- PedFuse Pedicle Screw System;... | Dec 19, 2014 |
| Z-0576-2014 | Class II | Indus Invue Screws: IM71013-XX: Indus Screw04.0... | Nov 20, 2013 |
| Z-0554-2014 | Class II | PedFuse Reset Screw Inserters; PedFuse Screw In... | Nov 20, 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.