Recall Z-0316-2018 ยท OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Amendia, Inc
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.
| Date | Jul 7, 2017 |
| Status | Terminated |
| 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. |
| Root cause | Mixed-up of materials/components |
| Action | The firm, Amendia, sent an "URGENT: MEDICAL DEVICE RECALL" letter to its Customers. The letter described the product, problem and actions to be taken. The customers were Instructed to examine inventory and quarantine affected products, notify customers if affected products were further distributed, coordinate the return of affected products back to Amendia by emailing: jconover@amendia.com or call 770-575-5236 or jwilliamson@amendia or call 770-575-5369, and to complete and return the Response Form. If there are questions, Amendia Customer Service can be contacted at 770-575-5224. |
| Quantity | 40 screws |
| Distribution | Distributed to states of: AL, FL, GA, NY, TX, and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152972 | Amendia Stand-Alone Cervical System Amendia, Inc., Jan 14, 2016 |