Marietta, GA, United States
Amendia, Inc recalls
2 recalls recorded since 2018, most recently on 7 July 2017. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 7 July 2017
- Terminated
- 15 October 2019
- Reason
- Incorrect labeling for the lot of MAC Pins. Although the pins are laser as 460 mm in length, the pins are 60 mm in length.
- Distribution
- Distribution to Georgia, USA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0325-2018
- Mac Pin Non-Cannulated Screw, 6.5 x 60mm
Terminated Class II Medical devices
- Recall started
- 7 July 2017
- Terminated
- 15 October 2019
- 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.
- Distribution
- Distributed to states of: AL, FL, GA, NY, TX, and VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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 Ceres-C Stand-Alone Cervical System.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.