Opteryx Variable Rescue Screw, Part #CP2214, UDI: *+M711CP22140/$$801716012*. Packaged in heat-s...
FDA Device Recall #Z-2153-2017 — Class II — May 5, 2017
Recall Summary
| Recall Number | Z-2153-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 5, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Innovasis, Inc |
| Location | Salt Lake City, UT |
| Product Type | Devices |
| Quantity | 21 |
Product Description
Opteryx Variable Rescue Screw, Part #CP2214, UDI: *+M711CP22140/$$801716012*. Packaged in heat-sealed plastic bag. Product Usage: 4.5mm x 14mm Anterior Cervical Plate System Variable Rescue Screw. The Opteryx¿ Cervical Plate System is intended as a temporary fixation device used for correction and stabilization of the cervical spine. Variable angle screws are included to allow the physician greater flexibility when placing the plates and securing it to the vertebrae.
Reason for Recall
Opteryx Variable Rescue Screws are engraved with incorrect (larger) size (16 instead of 14).
Distribution Pattern
US Nationwide Distribution in the states of CA, UT, ID, TX, OH, and MN.
Lot / Code Information
Lot #1601
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-0644-2018 | Class II | Excella II Polyaxial Pedicle Screw used as a pe... | Jan 8, 2018 |
| 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.