FDA Enforcement
Class II
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
·
Reported January 18, 2017
Enforcement
- Recall Number
- Z-0966-2017
- Event ID
- 75857
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Amendia, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- January 18, 2017
- Initiation Date
- November 22, 2016
- Classification Date
- January 9, 2017
- Termination Date
- February 28, 2017
- Address
- 1755 W Oak Pkwy, Marietta, GA, 30062-2260, United States
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.
Code Info
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
Distribution
US Distribution to GA only.
Quantity
6 devices