5.5mm Diameter x 500mm CoCr Straight Rod, Model number X077-0420. The product is packaged in pla...
FDA Device Recall #Z-1884-2017 — Class II — April 12, 2017
Recall Summary
| Recall Number | Z-1884-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 12, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | XTANT MEDICAL INC |
| Location | Belgrade, MT |
| Product Type | Devices |
| Quantity | 97 units |
Product Description
5.5mm Diameter x 500mm CoCr Straight Rod, Model number X077-0420. The product is packaged in plastic bags with one piece per bag. Product Usage: The 5.5mm dia. X 500 mm CoCr Straight Rod is an accessory to the Fortex Pedicle Screw System. It is a straight rod connected between two or more pedicle screws to create a pedicle screw construct. Indications for Use: The Fortex Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. In addition, the system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
Reason for Recall
The material type on the label may incorrectly state Ti6Al-4V ELI. The rods are composed of Cobalt Chromium.
Distribution Pattern
Worldwide distribution - US Nationwide in the states of: AZ, CA, CT, GA, LA, NV, OH, TX and in the country of Mexico.
Lot / Code Information
Part number X077-0420, lot number 041218
Other Recalls from XTANT MEDICAL INC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1526-2020 | Class II | OsteoSelect Demineralized Bone Matrix (DBM) Put... | May 3, 2019 |
| Z-0790-2019 | Class II | Calix Lumbar Spinal Implant System: 22mm x 10m... | Dec 19, 2018 |
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.