Chesapeake Cervical-Ti 10mm Drill Guide Inserter- a multi-screw construct providing stability to ...
FDA Device Recall #Z-1410-2021 — Class II — March 16, 2021
Recall Summary
| Recall Number | Z-1410-2021 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 16, 2021 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | K2M, Inc |
| Location | Leesburg, VA |
| Product Type | Devices |
| Quantity | 1 unit |
Product Description
Chesapeake Cervical-Ti 10mm Drill Guide Inserter- a multi-screw construct providing stability to the anterior column (cervical spine) Catalog number: 3608-90033
Reason for Recall
Interference condition between the 10mm Drill Guide Inserter and the inner shaft that mates with the inserters. As a result, inner shafts do not mate flush with the collet inserters, and splaying of the collet. If implant falls into the spinal cord may cause a spinal cord injury or Incomplete seating of the inserter to the implant could result in misalignment of the screws with the inserter screw guide, potentially causing malposition of the screws into the adjacent vertebral bodies
Distribution Pattern
PA
Lot / Code Information
Lot Number: MNAJ GTIN: 10888857082571
Other Recalls from K2M, Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0706-2022 | Class II | Everest MI XT Outer Dilator, Catalog Number 510... | Jan 13, 2022 |
| Z-0705-2022 | Class II | Everest MI XT Inner Dilator, Catalog Number 510... | Jan 13, 2022 |
| Z-0104-2022 | Class II | Chesapeake Anterior Lumbar (AL) Removal Tool; C... | Sep 8, 2021 |
| Z-1697-2021 | Class II | Cascadia AN Interbody Convex 10x28x14mm Cata... | May 7, 2021 |
| Z-1696-2021 | Class II | Cascadia AN Interbody Convex 10x22x15mm Cata... | May 7, 2021 |
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.