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 vertebral body replacement device - Product Code MQP
원인
The device was not appropriately set to mitigate the risk of implant fracture upon rotation inside the disc space.
조치
Atlas Spine, Inc. informed all consignees of the recall and sub-recall on July 26, 2013, in person, electronically, and/or via email. Firm takes the responsibility of tracking of set return and inventory control of the product.
For questions regarding this recall call 561-354-1108, ext 102.