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.
The firm received complaints that the device was damaged or fractured while the surgeon was bending it prior to implantation. there were also complaints that the cam may dislodge during tightening. the firm added additional instructions for use to reduce the probability of these two types of events.
조치
The firm provided a revised surgical technique document to the Zimmer spine sales force in January, 2009. The firm will provide an Urgent Medical Device Correction notification to speedlink users through the sales force.
The devices are contained in implant cases stocked by Zimmer spine and made available to the Zimmer sales force for surgeries. They are not in general distribution.
제품 설명
SpeedLink 5.5 Transverse Connector Short 39.5-44mm, non-sterile, 1302-55S