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
Bracket, Metal, Orthodontic - Product Code EJF
원인
Misassembly. stainless steel and titanium parts were mistakenly welded together to construct the device. the weld failed.
조치
Recall letters were mailed from 11/18 thru 11/23. Letters request return of product.