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.
Under new testing protocols for mr environment safety and compatibility, metal devices are no longer designated mr safe. some components in the cmf mandible external fixator systems were labeled and/or etched with information indicating they are mr safe. they can no longer be labeled mr safe.
조치
Urgent notices of medical device labeling updates, dated October 17, 2014 and October 24, 2014 were sent to end users and sales consultants, which described the product, problem, and action to be taken. These consignees were instructed to inspect inventory and remove out-dated labeling inserts and replace with updated labeling information.
The Synthes Mandible External Fixator; all lots of part nos.: || 04.305.003 || 04.305.004 || 04.305.005 || 04.305.010 || 04.305.011 || 04.305.012 || 03.305.006 || 04.305.100 || 04.305.101 || 04.305.102 || 04.305.103 || 04.305.128 || 04.305.130 || 04.305.134 || 04.305.138 || 04.305.140 || 04.305.142 || 03.305.105 || 03.305.500 || 03.305.500S || Intended to stabilize and provide treatment for fractures of the maxillofacial area, including severe open mandibular fractures, highly comminuted closed fractures, nonunions and delayed unions (especially associated with infection), fractures associated with infections, tumor resections, facial deformity corrections, gunshot wounds, pan facial fractures, burn maintenance, and bone grafting defects.