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
Plate, fixation, bone - Product Code HRS
원인
The drill template and the saw guide for the ulna osteotomy system may exhibit jamming, bending, or breaking of the screw connecting the saw guide to the drill template or jamming, bending, or breaking of the k-wire during fixation of the drill template.
조치
A recall notification letter, dated January 7, 2013, was sent to sales consultants and Users.
Nationwide Distribution-including the states of AR, AK, VA, IN, PA, OH, CT, TX, MI, WI, NC, CO, IL, and MA.
제품 설명
Drill Template and the Saw Guide for the Ulna Osteotomy System. || Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, including osteopenic bone in the ulna.