FDA Device recall Z-0316-2018
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 Cere…
- FDA Device
- Class II
- terminated
- Published 2018-01-10
On 2018-01-10 the FDA classified a Class II recall of 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 Cere… by Amendia, citing 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 le….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0316-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-07-07 |
| Published | 2018-01-10 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Amendia |
| Distribution | AL, FL, GA, NY, TX, VA |
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
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.
Identifiers
| code_info | Model # 12-31-4012, Lot #133039 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0316-2018%22
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