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Amendia, Inc recalls Ceres Self-Drilling Variable Screw 4.0 x 12mm The Ceres screws are self-drilling variable screws that are intended to
Recalled January 10, 2018 · FDA recall Z-0316-2018 · Amendia
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. · FDA Class II
Units
40 screws
Sold at
Distributed to states of: AL, FL, GA, NY, TX, and VA.
Description
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.
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.
Manufacturer(s)
Amendia, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →