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 apex knee system modular tibia augment may breach the inner and outer sterile pouches, compromising the sterility.
조치
Omnilife Science contacted affected customers by phone and sent an "URGENT MEDICAL DEVICE RECALL" e-mail on August 9, 2012. The e-mail identifies the product, problem, and actions to be taken by the customers. Customers with questions regarding product return should contact Customer Service at 800-448-6664. Customers with questions regarding the recall should contact the firm at 774-226-1845.
Worldwide Distribution-USA (nationwide including the states of CO, NY, OK, PA, UT, VA, and WI, and the countries of Spain and the Netherlands.
제품 설명
Omnilife Science Apex Knee System Modular Tibia Augment, Size 3 x 4mm || Ref: KC-54030. || The Apex Knee System is intended for use as a primary or revision total knee replacement.