Recall Z-0966-2017 ยท OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Amendia, Inc
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.
| Date | Jan 9, 2017 (initiated Nov 22, 2016) |
| Status | Terminated |
| Reason | Absent tantalum market pin. |
| 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 bbrosseau@securebme.com with any questions or concerns regarding this recall notification. |
| Quantity | 6 devices |
| Distribution | US Distribution to GA only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152972 | Amendia Stand-Alone Cervical System Amendia, Inc., Jan 14, 2016 |