Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Ceres Self-Drilling Variable Screw 4.0 x 12mm The Ceres screws Recalled by Amendia, Inc Due to Incorrect direct marking and color identification for the...

Date: July 7, 2017
Company: Amendia, Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Amendia, Inc directly.

Affected Products

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.

Quantity: 40 screws

Why Was This 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.

Where Was This Sold?

This product was distributed to 6 states: AL, FL, GA, NY, TX, VA

Affected (6 states)Not affected

About Amendia, Inc

Amendia, Inc has 11 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report