K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qt...
FDA Device Recall #Z-2018-2020 — Class II — April 13, 2020
Recall Summary
| Recall Number | Z-2018-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 13, 2020 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | K2M, Inc |
| Location | Leesburg, VA |
| Product Type | Devices |
| Quantity | N/A |
Product Description
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90137, UDI # 10888857108509, Size 24x6mm, 18 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal implant size base on patient anatomy.
Reason for Recall
The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
Distribution Pattern
Worldwide distribution - US Nationwide distribution including in the states of Colorado, Michigan, Texas, California, New York, Florida, Maryland, Oregon, Kansas, Montana, Missouri and the country of Europe.
Lot / Code Information
Lot # FKXG
Other Recalls from K2M, Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0705-2022 | Class II | Everest MI XT Inner Dilator, Catalog Number 510... | Jan 13, 2022 |
| Z-0706-2022 | Class II | Everest MI XT Outer 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-1695-2021 | Class II | Cascadia AN Interbody Convex 10x22x14mm Catalo... | 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.