Z-0316-2018Class II

Ceres Self-Drilling Variable Screw 4.0 x 12mm The Ceres screws are self-drilling variable screws that are...

Name: Z-0316-2018 Ceres Self-Drilling Variable Screw 4.0 x 12mm The Ceres screws are self-drilling variable screws that are...
Creator: Amendia, Inc
Published: 2017-07-07
License: https://open.fda.gov/license/

Spinal Elements, Inc / initiated 2017-07-07 / Terminated

FDA source

Amendia, Inc began a recall of 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... on 2017-07-07. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0316-2018
Classification: Class II
Status: Terminated
Initiated: 2017-07-07
Posted: 2018-01-04
Terminated: 2019-10-15
Recalling firm: Spinal Elements, 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.
Product code: OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
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.
FDA 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: [email protected] 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 in commerce: 40 screws
Distribution: Distributed to states of: AL, FL, GA, NY, TX, and VA.
Product codes and lots: Model # 12-31-4012, Lot #133039

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0316-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0316-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-10	2018-01-04

Product code OVE

K152972Class IIAmendia Stand-Alone Cervical SystemAmendia, Inc. / cleared 2016-01-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)