Ceres-C Standalone Cervical Interbody The product is a stand-alone anterior cervical interbody fusion device indicated f
FDA device recall Z-0966-2017 · posted 2017-01-09 · Terminated
Recall details
- Recalling firm
- Amendia, Inc
- Reason for recall
- Absent tantalum market pin.
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- OVE
- Quantity affected
- 6 devices
- Distribution
- US Distribution to GA only.
- Date initiated
- 2016-11-22
- Date posted
- 2017-01-09
- Date terminated
- 2017-02-28
- Location
- Marietta, GA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Amendia Stand-Alone Cervical System (K152972) | Amendia, Inc. | 2016-01-14 |