Drug recall
Ceres Self-Drilling Variable Screw 4.0 x 12mm The Ceres screws are self-drilling variable screws that are…
FDA recall event 77986 · Class II · Amendia, Inc
Key facts
| Event ID | 77986 |
|---|---|
| Recall numbers | Z-0316-2018 |
| Recalling firm | Amendia, Inc |
| Product type | Devices |
| Products | 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. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Jul 7, 2017 |
| Report date | Jan 10, 2018 |
| Termination date | Oct 15, 2019 |
| City | Marietta |
| State | GA |
| Country | United States |
| FEI number | 3007970248 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: