WHY STRYKER RECALLED REJUVENATE ABG II
STRYKER OFFICIAL RECALL ANOUNCEMENT ,DATED JULY ,6,2012 STATED THAT THE COMPANYS DESCION TO REMOVE REJUVENATE AND ABGII STEMS AND TERMINATE GLOBAL DISTRIBUTION OF THESE PRODUCTS COMES AFTER CONTINUED POST -MARKET SUIRVELLANCE THE COMPANY VICE PRESIDENT AND GENERAL MANAGER OF HIP RECONSTRUCTIONSTUART SIMPSON ADDED: FOLLOWING THIS ACTION WE WILL WORK WITH THE MEDICAL COMUNITY TO BETTER UNDERSTAND THIS MATER AS WE CONTINUED TO EVALUATE THE DATA.
THE NECK COMPONENT OF THE REGUVENATE ABGII ARE MADE OF CHROMIUM AND COBALT AND THE STEMS IS COATED WITH TITANIUM.WHEN THESE PARTS WEAR AGAINST EACH OTHER , WHERE THE NECK MEETS THE STEAM THEY CAN SHED METALIC DEBRIS INTO THE BODY AND LEAD COMPLICATIONS .
IN AN URGENT FIELD SAFETY NOTICE ISSUED IMEDIATLY BEFORE THE RECALL, STRYKER WARNED THAT POST DATA REVEALED THAT THE REJUVENATE AND ABGII INCEASED RATE IN ADVERSE LOCAL TISSUE REACTION MEANING COMPLICATION ARISING FROM INFLAMATIOIN IN THE TISSUE IN AND AROUND THE IMPLANT.
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STRYKER OFFICIAL RECALL ANOUNCEMENT ,DATED JULY ,6,2012 STATED THAT THE COMPANYS DESCION TO REMOVE REJUVENATE AND ABGII STEMS AND TERMINATE GLOBAL DISTRIBUTION OF THESE PRODUCTS COMES AFTER CONTINUED POST -MARKET SUIRVELLANCE THE COMPANY VICE PRESIDENT AND GENERAL MANAGER OF HIP RECONSTRUCTIONSTUART SIMPSON ADDED: FOLLOWING THIS ACTION WE WILL WORK WITH THE MEDICAL COMUNITY TO BETTER UNDERSTAND THIS MATER AS WE CONTINUED TO EVALUATE THE DATA.
THE NECK COMPONENT OF THE REGUVENATE ABGII ARE MADE OF CHROMIUM AND COBALT AND THE STEMS IS COATED WITH TITANIUM.WHEN THESE PARTS WEAR AGAINST EACH OTHER , WHERE THE NECK MEETS THE STEAM THEY CAN SHED METALIC DEBRIS INTO THE BODY AND LEAD COMPLICATIONS .
IN AN URGENT FIELD SAFETY NOTICE ISSUED IMEDIATLY BEFORE THE RECALL, STRYKER WARNED THAT POST DATA REVEALED THAT THE REJUVENATE AND ABGII INCEASED RATE IN ADVERSE LOCAL TISSUE REACTION MEANING COMPLICATION ARISING FROM INFLAMATIOIN IN THE TISSUE IN AND AROUND THE IMPLANT.
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