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
Implantable Staple - Product Code GDW
원인
The ethicon securestrap 5 mm absorbable strap fixation device may have the potential for the sterile barrier to be compromised due to a defect in the packaging.
조치
Ethicon sent Urgent Voluntary Product Recall letters dated, December 28, 2010, to their customers on December 29, 2010 via UPS. The letter identified the affected product and described the reason for recall. Customers are to discontinue use and sampling immediately. They are to return the product using the enclosed prepaid shipping label along with the enclosed business reply card regardless of whether they have any affected product or not. Customers should contact 1-877-551-7147 or speak to their manager if they have questions regarding this recall.
Ethicon SecureStrap 5 mm Absorbable Strap Fixation Device Product Code STRAP25. || Intended for fixation of prosthetic material to soft tissues in various minimally invasive and open surgical procedures, such as hernia repairs.