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
Device, prosthesis alignment - Product Code IQO
원인
A drafting error during an unrelated design change has led to 4 misleading dimensions on the drawing. the cad model
remained the same thickness but the problem dimensions were accidentally struck from an incorrect point result in an
increase of 1.0mm in the value of each dimension.
조치
Biomet sent a "FIELD SAFETY CORRECTIVE ACTION" letter dated July 24, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Response Form was attached for customers to complete and return. Contact the firm for questions regarding this notice.
Worldwide Distribution-USA-including the states of IN, SD, and TX and the countries of Austria, China, Japan, Netherlands, Sweden, Turkey, and UK.
제품 설명
Oxford Gap Gauge SML 3/4mm. || The instrument is used for an intermediate check of the flexion and extension gaps when preparing the femur to accept the femoral component.
“The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.