U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Intervertebral fusion device with integrated fixation, cervical - Product Code OVE
원인
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.
조치
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.
Distributed to states of: AL, FL, GA, NY, TX, and VA.
제품 설명
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.