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
Appliance, fixation, spinal intervertebral body - Product Code KWQ
원인
Shipped to a single consignee prior to completion of final inspection.
조치
Exactech contacted their consignee by telephone on May 21, 2015, of this recall for their two products and instructed him to recover the devices from the hospital. Devices were recovered from the hospital May 22, 2015, and returned to the firm on May 26. All devices have been recovered.
Exactech Ambassador Cervical Plate System || The Exactech Ambassador Cervical Place System is intended for anterior cervical fixation (C2-T1) for the following: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.