Aegis Torque Handle CATALOG NO. : 2871-10-800. A spinal surgical instrument used on the AEGIS An...
FDA Device Recall #Z-0454-2016 — Class II — November 20, 2015
Recall Summary
| Recall Number | Z-0454-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 20, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | DePuy Spine, Inc. |
| Location | Raynham, MA |
| Product Type | Devices |
| Quantity | 16 devices |
Product Description
Aegis Torque Handle CATALOG NO. : 2871-10-800. A spinal surgical instrument used on the AEGIS Anterior Lumbar Plate System.
Reason for Recall
Manufacturing error within the Torque Handle may prohibit some handles from being able to fully assemble with the tightener shaft. The design of the inspection gage does not account for the additional shift length
Distribution Pattern
US Distribution to the states of : NC, MI, CO, MD, FL, ID, TX, CA and NY.
Lot / Code Information
LOT NUMBER: GB0906 GB0707 GB0907 GB58815 GB59244 GB61134
Other Recalls from DePuy Spine, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1323-2022 | Class II | EIT CIF cage, H 6mm, 8degree, L- an interverteb... | May 20, 2022 |
| Z-1324-2022 | Class II | EIT CIF cage, H 7mm, 8degree, S- an interverteb... | May 20, 2022 |
| Z-1226-2019 | Class II | Concorde Lift, Lordotic Expandable Interbody De... | Apr 8, 2019 |
| Z-1225-2019 | Class II | Concorde Lift, Expandable Interbody Device, spi... | Apr 8, 2019 |
| Z-1300-2018 | Class II | Confidence Plus Kit Spinal Cement System, Produ... | Dec 15, 2017 |
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.