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
Blade - Product Code GFA
원인
The blades will oxidize after the first cleaning.
조치
Distributors were notified via letter dated 7/18/08 to locate and remove the products and to return them. Distributors were instructed to conduct the recall to the hospital level and to notify the hospitals of the recall by copy of an undated recall letter. Contact Biomet, Inc. at 1-800-348-9500, ext. 3983 for assistance.
Exact Calcar Planer Rasp Style Blade, 38mm, Biomet Orthopedics, Inc, Warsaw, IN; REF 31-473795. Surgical blades used to remove excess bone proximal to the broach face to all instrument trial to seat properly.