Z-0966-2017Class II

Ceres-C Standalone Cervical Interbody The product is a stand-alone anterior cervical interbody fusion device...

Name: Z-0966-2017 Ceres-C Standalone Cervical Interbody The product is a stand-alone anterior cervical interbody fusion device...
Creator: Amendia, Inc
Published: 2016-11-22
License: https://open.fda.gov/license/

Spinal Elements, Inc / initiated 2016-11-22 / Terminated / root cause: manufacturing process

FDA source

Amendia, Inc began a recall of Ceres-C Standalone Cervical Interbody The product is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients... on 2016-11-22. FDA classified it as Class II and gives the reason as "Absent tantalum market pin". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0966-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-22
Posted: 2017-01-09
Terminated: 2017-02-28
Recalling firm: Spinal Elements, Inc
Product: Ceres-C Standalone Cervical Interbody The product is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at the one level from C2-T1.
Product code: OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Reason for recall: Absent tantalum market pin.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm, Amendia, contacted the consignee and issued a Return Material Authorization for the affected product on 8/18/2016. Please contact Regulatory and Quality Consultant for Amendia at 404-610-7215 or by email to [email protected] with any questions or concerns regarding this recall notification.
Quantity in commerce: 6 devices
Distribution: US Distribution to GA only.
Product codes and lots: Part Number 08-170-1010 - Lot Number 134926; Part Number 08-170-1011 - Lot Number 134927; Part Number 08-170-1006 - Lot Number 134929; Part Number 08-170-1008 - Lot Number 134931

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0966-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0966-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-18	2017-01-09

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)