Ceres-C Standalone Cervical Interbody The product is a stand-alone… — Class II medical device recall Z-0966-2017
Terminated recall by Amendia, Inc, reported 2017-01-18. Absent tantalum market pin.
| Recall number | Z-0966-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amendia, Inc, Marietta, GA, United States |
| Recall initiated | 2016-11-22 |
| Classified | 2017-01-09 |
| Reported by FDA | 2017-01-18 |
| Terminated | 2017-02-28 |
| Quantity | 6 devices |
| Lot numbers | 134926, 134927, 134929, 134931 |
| Model numbers | 08-170-1006, 08-170-1008, 08-170-1010, 08-170-1011 |
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.
Reason for recall
Absent tantalum market pin.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0966-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.