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
Sutures - Product Code MBI
원인
Sterility compromised (package integrity): sterility of the device may be compromised due to holes in the sterile packaging.
조치
Axya Medical notified customers by letter, Urgent-Product Recall, dated 9/25/07 , via UPS . Users are requested to return product and complete the reply form.