FDA-Device2018-01-10Class II
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.
Amendia, Inc
Hazard
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.
Sold states
Distributed to states of: AL, FL, GA, NY, TX, and VA.
Affected count
40 screws
Manufactured in
1755 W Oak Pkwy, N/A, Marietta, GA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0316-2018Don't want to check this manually?
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