Streamline MIS Spinal Fixation System Fixed Rod Holder NON STERILE, Rx only The Streamline MI...
FDA Device Recall #Z-2616-2014 — Class II — June 14, 2013
Recall Summary
| Recall Number | Z-2616-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 14, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | PIONEER SURGICAL TECHNOLOGY, INC. |
| Location | Marquette, MI |
| Product Type | Devices |
| Quantity | 9 |
Product Description
Streamline MIS Spinal Fixation System Fixed Rod Holder NON STERILE, Rx only The Streamline MIS Spinal Fixation System is intended for posterior, noncervical pedicle fixation, T1-S2. Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion. The device is indicated for all the following indications: degenerative disc disease (ODD) (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, kyphosis, and /or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The Streamline MIS instrumentation, when used with the Streamline MIS Spinal Fixation System, is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.
Reason for Recall
The affected fixed rod holders did not allow the instrument to lock down on the spinal rod.
Distribution Pattern
Nationwide Distribution including TX, CA, IL, and FL.
Lot / Code Information
Lot number: 148062, 148440
Other Recalls from PIONEER SURGICAL TECHNOLOGY, INC.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2076-2014 | Class II | Tritium Sternal Plate System, Screw, 02.7mm X 1... | Jun 11, 2014 |
| Z-2573-2014 | Class II | STREAMLINE CT CERVICO-THORACIC SYSTEM; SET SCRE... | Sep 10, 2012 |
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.