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
Suture, surgical, absorbable, polydioxanone - Product Code NEW
원인
Ethicon stratafix symmetric pds plus knotless tissue control device has a small number of tab failures and fascial dehiscences in lower abdominal incisions.
조치
Ethicon Inc. sent recall notifications/business reply forms on 9/25/2013 via UPS next day certified mail.
Worldwide Distribution-USA (nationwide) and countries of: Caribbean, Chile, Singapore and Malaysia.
제품 설명
Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Ethicon LLC Guaynabo, Puerto Rico 00969. || Intended for general soft tissue approximation where use of an absorbable suture is appropriate.