FDA recall Z-0316-2018

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.

Reason for recall

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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2017-07-07

Report date

2018-01-10

Termination date

2019-10-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Marietta, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0316-2018