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
Gutta-percha - Product Code EKM
원인
Ormco corporation is recalling the tf adaptive gutta percha point size sm3-50pk because the inner generic label is identified as ml3. the products outer package is identified as sm3 which matches the product inside.
조치
An Urgent Medical Device Recall letter dated February 8, 2016 was sent to all customers. The letter identified the affected product, problem and actions to be taken. Customers are instructed to complete and fax back the enclosed acknowledgement form to 909-962-5605 to confirm receipt of the recall notification .