FDA Recall
Terminated
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.
Recall: Z-0966-2017
·
Initiated November 22, 2016
Recall
- Recall Number
- Z-0966-2017
- Event Number
- 75857
- Firm
- Amendia, Inc
- FEI Number
- 3007970248
- Product Code
- OVE
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- November 22, 2016
- Posted
- January 9, 2017
- Terminated
- February 28, 2017
- Address
- 1755 W Oak Pkwy, Marietta, GA, 30062-2260
Description
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.
Reason
Absent tantalum market pin.
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.
Distribution
US Distribution to GA only.
Quantity
6 devices