Amendia, Inc recalls Ceres Self-Drilling Variable Screw 4.0 x 12mm The Ceres screws are self-drilling variable screws that are intended to b…

Recall date

July 7, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0316-2018

FDA classification

Class II

Brand / firm

Amendia, Inc

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.