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
Appliance, fixation, spinal intervertebral body - Product Code KWQ
원인
The devices may fracture, resulting in surgical delay or the need for intervention to remove fragments from the surgical site.
조치
The affected instruments were removed and replaced in the U.S. Abbott Spine and Spinal Concepts instrument kits between December 2005 and October 2007. User accounts were not advised of the removal Zimmer has confirmed that none of these instruments are currently available for use in the U.S.
For further information about this action, contact Dale Miller of Zimmer at 574 372-4962.