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
Rod, fixation, intramedullary and accessories - Product Code HSB
원인
Medacta has registered in its database 3 cases of breakage of the gmk intramedullary extension
rod 100 mm, code 02.07.10.0162.
조치
Medacta sent an URGENT MEDICAL DEVICE letter dated September 22, 2014 to the sole US consignee. The letter included instructions for the consignee to: 1) check its inventory of the device; 2) quarantine and do not use the recalled device; and, 3) return the recalled device upon receipt of a RMA # from the Medacta QA Department. For questions regarding this recall call 805-910-6511.
Worldwide Distribution - US including OH and Internationally to Australia, Austria, Belgium, France, Germany, Greece, Italy, Japan, Portugal, South Africa, Spain, and Switzerland.
제품 설명
GMK Intramedullary Extension Rod 100 mm is a rod to obtain correct leg alignment during total knee replacement. || Rod to obtain correct leg alignment during total knee replacement.