Amendia, Inc: 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.

Recall number

Z-0316-2018

Recalling firm

Amendia, Inc

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.

Status

Terminated

Initiated

2017-07-07

Posted

not on file

Terminated

2019-10-15

Reason

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.

Root cause

Mixed-up of materials/components

Action

The firm, Amendia, sent an "URGENT: MEDICAL DEVICE RECALL" letter to its Customers. The letter described the product, problem and actions to be taken. The customers were Instructed to examine inventory and quarantine affected products, notify customers if affected products were further distributed, coordinate the return of affected products back to Amendia by emailing: jconover@amendia.com or call 770-575-5236 or jwilliamson@amendia or call 770-575-5369, and to complete and return the Response Form. If there are questions, Amendia Customer Service can be contacted at 770-575-5224.

Quantity

40 screws

Distribution

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

Lot, serial or model codes

Model # 12-31-4012, Lot #133039

510(k) numbers

["K152972"]

PMA numbers

not on file

Product code

OVE

Firm FEI

3007970248

Firm city

Marietta

Firm state

GA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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