Excella II Polyaxial Pedicle Screw used as a pedicle screw system in skeletally mature patients, ...
FDA Device Recall #Z-0644-2018 — Class II — January 8, 2018
Recall Summary
| Recall Number | Z-0644-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 8, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Innovasis, Inc |
| Location | Salt Lake City, UT |
| Product Type | Devices |
| Quantity | 1,010 parts |
Product Description
Excella II Polyaxial Pedicle Screw used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic deformities of the thoracic, lumbar, and sacral spine:
Reason for Recall
Nine lots of 8.5 mm Polyaxial Pedicle Screws are at risk of breakage.
Distribution Pattern
United States
Lot / Code Information
Catalog/Part No.: E2S8530, E2S8535, E2S8540, E2S8545, E2S8550, E2S8555, E2S8560 with Lot Number: 1101 and Catalog/Part No.: E28540, E28545 with Lot Number: 1201. Each of these parts is engraved with part number and lot number.
Other Recalls from Innovasis, Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-3163-2024 | Class II | TxHA PEEK IBF/TxTiHA IBF System REF BTA-151 ... | Aug 14, 2024 |
| Z-2062-2020 | Class II | Oryx Cervical Screw Caddy, Model Number BTA-172... | Apr 7, 2020 |
| Z-2153-2017 | Class II | Opteryx Variable Rescue Screw, Part #CP2214, UD... | May 5, 2017 |
| Z-0662-2016 | Class II | Excella II Rod Cat. No.: SR 55100 5.5 x 100 mm... | Dec 7, 2015 |
| Z-2067-2014 | Class II | Excella II Standard Pedicle Screw, Catalog No. ... | Jul 7, 2014 |
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.