# FDA recall Z-0316-2018

> **Amendia, Inc** · Class II · device recall initiated 2017-07-07.

## 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.

## Distribution

Distributed to states of: AL, FL, GA, NY, TX, and VA.

## Key facts

- **Recall number:** Z-0316-2018
- **Recalling firm:** Amendia, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-07-07
- **Report date:** 2018-01-10
- **Termination date:** 2019-10-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Marietta, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0316-2018

## Citation

> AI Analytics. FDA recall Z-0316-2018. Retrieved 2026-07-01 from https://api.ai-analytics.org/recall/Z-0316-2018. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*