Devices

Device Recall Ceres SelfDrilling Variable Screw 4.0 x 12mm

Model / Serial
Model # 12-31-4012, Lot #133039
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Distributed to states of: AL, FL, GA, NY, TX, and VA.
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.
Manufacturer
Amendia, Inc
1 Event
- Recall of Device Recall Ceres SelfDrilling Variable Screw 4.0 x 12mm

Manufacturer

Amendia, Inc

Manufacturer Address
Amendia, Inc, 1755 W Oak Pkwy, Marietta GA 30062-2260
Manufacturer Parent Company (2017)
Spinal Elements
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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