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
spinal implant component - Product Code KWQ
원인
Surgeons may apply an accidental axial torque to and/or over-angulate the all-in one guide while implanting the screw. this may cause the screw not to seat properly in the locking ring and may cause the thor screwdrivers to twist or break at the tip.
조치
Recall notification letters were sent to all Stryker branches, Hospital Risk Management and Surgeons on October 19, 2009 by Federal Express. Questions are to be directed to Tiffani Rogers, Regulatory Compliance Manager at 201-760-8206.