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.
Possible inner labeling and packaged device not matching the outer label on the box.
조치
Customers were notified via letter dated May 16, 2017. Instructions included to immediately cease distribution of the affected products, identify and quarantine any devices in inventory, complete and return the Recall Inventory Response Form, notify customers if further distributed. For further questions, please call (352) 377-1140.
Vantage Total Ankle Tibial Insert, Fixed Bearing, 7 mm, Left, Size 3. Exactech Inc., || Intended for patients with ankle joints damage by severe rheumatoid, post-traumatic, or degenerative arthritis. It is also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. Indicated for cemented use only.