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
Guide, surgical, instrument - Product Code FZX
원인
One lot of matrix mandible short threaded drill guides (part no. 03.503.043) has a gray colored band instead of a green colored band as pictured in the technique guide.
조치
A recall letter, dated January 27, 2014, was sent to end users and sales consultants.
Synthes Matrix Mandible Short Threaded Drill Guide intended for oral, maxillofacial surgery; trauma and reconstructive surgery, specifically for fractures of the subcondylar region of the mandible and fractures of the condylar basis region of the mandible.