Z-0316-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 10, 2018
- Initiation Date
- July 7, 2017
- Termination Date
- October 15, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 40 screws
Product Description
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 Pattern
Distributed to states of: AL, FL, GA, NY, TX, and VA.
Code Information
Model # 12-31-4012, Lot #133039