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
Product does not meet minimum knot tensile strength requirements.
조치
Consignees were notified by an Urgent Medical Device Recall Notification letter, dated 3/11/2014. The letter identified the affected product and the reason for recall. Customers were instructed to immediately discontinue use of and quarantine any affected product in stock. The affected product is to be returned; and the Recall Acknowledgement Form should be completed and faxed to the number provided regardless of whether customers have affected product in stock. Questions should be directed to a local sales rep or Customer Service at 1-866-246-6990.