Device Recall Stryker iVAS Inflatable Vertebral Augmentation System

  • Modelo / Serial
    1. Shelf Life: 12 months; Lot Number: 17277012; 2. Shelf Life: 36 months; Lot Numbers: 17283012, 17299012   UDI: (01)7613252505983; (01)7613252505969
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed in all 50 U.S. States and the District of Columbia. Distributed in Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, Netherlands, and United Kingdom.
  • Descripción del producto
    1. 11g/10mm iVAS System Kit, Product Number: 0705-310-000, UDI: (01)7613252505983; 2. 11g/15mm iVAS System Kit, Product Number: 0705-315-000, UDI: (01)7613252505969 || for spinal orthopedic use.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Stryker Instruments Div. of Stryker Corporation, 4100 E Milham Ave, Portage MI 49002-9704
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA