Ceres Self-Drilling Variable Screw 4.0 x 12mm The Ceres screws are self-drilling variable scre...

FDA Device Recall #Z-0316-2018 — Class II — July 7, 2017

Recall Summary

Recall Number Z-0316-2018
Classification Class II — Moderate risk
Date Initiated July 7, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Amendia, Inc
Location Marietta, GA
Product Type Devices
Quantity 40 screws

Product Description

Ceres Self-Drilling Variable Screw 4.0 x 12mm The Ceres screws are self-drilling variable screws that are intended to be used with the Ceres-C Stand-Alone Cervical System.

Reason for Recall

Incorrect direct marking and color identification for the affected lot of Ceres Self-Drilling Variable Screws. Although the laser mark and color identify the screws as 12 mm in length, some screws in the lot measure 14 mm in length.

Distribution Pattern

Distributed to states of: AL, FL, GA, NY, TX, and VA.

Lot / Code Information

Model # 12-31-4012, Lot #133039

Other Recalls from Amendia, Inc

Recall # Classification Product Date
Z-0325-2018 Class II Mac Pin Non-Cannulated Screw, 6.5 x 60mm Jul 7, 2017
Z-1885-2017 Class II 01.4mm x 457mm (18in) K-Wire, Threaded Blunt, R... Apr 6, 2017
Z-0881-2017 Class II K-Wire 1.4mm x 12in Non-Threaded, Part Number 9... Nov 22, 2016
Z-0887-2017 Class II Black Widow 6.6mm x 20mm Screw, Part Number TBS... Nov 22, 2016
Z-0827-2017 Class II Zeus-P Lumbar Interbody Device Nov 22, 2016

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.