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
Arthroscope accessory - Product Code HRX
원인
Sterrad 100s parameters provided in the shaver handpiece reprocessing guide (p10299 revision a) did not fully consider all worst-case scenarios during validation testing.
조치
Device Correction letters were sent on May 23, 2014 to all users by certified mail. Internation sites will receive notification and be responsible for contacting customers.