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
Thoracolumbosacral pedicle screw system - Product Code NKB
원인
Incorrect labeling for the lot of mac pins. although the pins are laser as 460 mm in length, the pins are 60 mm in length.
조치
Customers were sent recall notification letters on 07/07/2017. Instructions included to examine inventory and quarantine affected products, notify customers if affected products were further distributed, coordinate the return of affected products back to Amendia, and to complete and return the questionnaire. If there are questions, Amendia Customer Service can be contacted at 770-575-5224.