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
Intramedullary Fixation Rod and Accessories - Product Code HSB
원인
Certain lots of raw material contain inclusions that could potentially reduce the strength of some devices.
조치
Letters to Biomet/EBI reps were sent on March 29, 2009 by US mail to alert them of the product recall and the affected parts that may be in their possession. They were also asked to notify each customer and locate all affected inventory. All letters advised of the recall and the specific lot numbers involved. A letter was sent to the hospital and physician that received affected parts and asked that implanting physicians make any medical decisions.
Uniflex Ti Buttress Thread Screw; || TI Screw Buttress Thread || Trauma Fixation Systems, Rx only || Biomet, 100 Interpace Parkway, Parsippany, NJ 07054 || Intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred.