Recall Z-0966-2017
Amendia, Inc · initiated November 22, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / 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
Reason for recall
Absent tantalum market pin.
FDA-determined cause: Process control
Action taken
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 bbrosseau@securebme.com with any questions or concerns regarding this recall notification.
Details
- Recall number
- Z-0966-2017
- Initiated
- November 22, 2016
- Posted by FDA
- January 9, 2017
- Terminated
- February 28, 2017
- Product code
- OVE – Intervertebral Fusion Device With Integrated Fixation, Cervical
- Quantity
- 6 devices
- Distribution
- US Distribution to GA only.
- Recalling firm
- Amendia, Inc, Marietta, GA