Device product
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.
Z-0316-2018
Product summary
- Firm
- Amendia, Inc
- Event
- Event 77986
- Status
- Terminated
- Classification
- Class II
- Quantity
- 40 screws
- Official record key
device-enforcement:Z-0316-2018
Official wording
Reason: 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.
Code information: Model # 12-31-4012, Lot #133039
Distribution pattern: Distributed to states of: AL, FL, GA, NY, TX, and VA.
Derived failure modes
-
Unknown
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.