Amendia, Inc: Medical Device Recall in 2018 - (Recall #: Z-0316-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: July 7, 2017

Date Posted: January 10, 2018

Recall Number: Z-0316-2018

Event ID: 77986

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.

Status: Terminated

Product Quantity: 40 screws

Code Information:

Model # 12-31-4012, Lot #133039

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated