Device Recall Bariatric Target Ring (Nitinol)

  • Modelo / Serial
    M/odel # K-9536-N, Lot #08-001, Lot #08-002 & Lot #08-003.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Product was distributed to the following states: OH, PA & SC. Product was also shipped to Saudia Arabia.
  • Descripción del producto
    Bariatric Target Ring (Nitinol) (a thin, circular nitinol ring) Model # K-9536-N, Lot #08-001, Lot #08-002 & Lot #08-003. One ring per plastic pouch, three rings are then placed into a plastic box with lid. This box is then placed into a solid white box. Item is shipped and sold non-sterile. || It is intended to be used to radiographically (with X-Ray) mark the site of the "gastropexy" performed during gastric bypass surgery, thereby making it accessible for future diagnostic, therapeutic and feeding purposes.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Kapp Surgical Instrument Inc, 4919 Warrensville Center Rd, Warrensville Heights OH 44128-4353
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA