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
Intervertebral fusion device with bone graft, lumbar - Product Code MAX
원인
The mectalif oblique handle has the laser marking "medial" on the incorrect side and could result in incorrect insertion of the device during surgery.
조치
Medacta sent an URGENT MEDICAL DEVICE RECALL letter dated October 21, 2014 were via e-mail to all sales representatives and distributors. The letters included instructions for the sales represetantives and distributors to: 1) check their inventory for the recalled devices; 2) immedaitely sequester the recalled devices and do not use them during surgery; 3) if the devices have been further distributed, inform them of the recall; and, 4) replacement devices will be provided.
Customers with questions can contact Medacta USA at 805-910-6511.