Ceres Self-Drilling Variable Screw 4 — Class II medical device recall Z-0316-2018
Terminated recall by Amendia, Inc, reported 2018-01-10, distributed in AL, FL, GA, NY, TX, VA. Incorrect direct marking and color identification for the affected lot of Ceres Self-Drilling Variable Screws.
| Recall number | Z-0316-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amendia, Inc, Marietta, GA, United States |
| Recall initiated | 2017-07-07 |
| Classified | 2018-01-04 |
| Reported by FDA | 2018-01-10 |
| Terminated | 2019-10-15 |
| Distributed | AL, FL, GA, NY, TX, VA |
| Quantity | 40 screws |
| Lot numbers | 133039 |
| Model numbers | 12-31-4012 |
Product
Ceres Self-Drilling Variable Screw 4.0 x 12mm The Ceres screws are self-drilling variable screws that are intended to be used with the Ceres-C Stand-Alone Cervical System.
Reason for recall
Incorrect direct marking and color identification for the affected lot of Ceres Self-Drilling Variable Screws. Although the laser mark and color identify the screws as 12 mm in length, some screws in the lot measure 14 mm in length.
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-0316-2018. 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.