Device Recall SurgASSIST System

  • Model / Serial
    Lot numbers DS-000036, DS-000043, DS-000047, DS-000049, DS-000052, DS-000055, DS-000057, DS-000061, DS-000064, DS-000072, DS-000073, DS-000077, DS-000078, DS-000082, DS-000084, DS-000085, DS-000086, DS-000090, DS-000095, DS-000099, DS-000117, DS-000118, DS-000119, DS-000126, DS-000132, DS-000133, DS-000135, DS-000138,  DS-000140, DS-000141, DS-000145, LC-000022, LC-000023, LC-000024, LC-000030, LC-000044, LC-000052, LC-000053, LC-000055, LC-000056, LC-000061, LC-000066, LC-000068, and LC-000074.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    The products were shipped to medical facilities and sales representatives nationwide. The products were also shipped to distributors in Belgium, Germany, Ireland, Israel, Italy, Japan, Netherlands, and Spain
  • Product Description
    SurgASSIST System. Circular Stapler DLU 29 mm (product code CS29)
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Power Medical Interventions, 110 Union Square Drive, New Hope PA 18938
  • Source
    USFDA

3 devices with a similar name

Learn more about the data here

  • Model / Serial
    Lot numbers DS-000122, DS-000123, DS-000127, DS-000134, DS-000139, DS-000142, DS-000146, and DS-000148.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    The products were shipped to medical facilities and sales representatives nationwide. The products were also shipped to distributors in Belgium, Germany, Ireland, Israel, Italy, Japan, Netherlands, and Spain
  • Product Description
    SurgASSIST System. Circular Stapler DLU 33 mm (product code CS33).
  • Manufacturer
  • Model / Serial
    Product Code CS29, Lot numbers LC-000125, LC000126, LC-000127, LC-000131, LC-000132, LC-000133, LC-000137, LC-000139, LC-000139-1, LC-000142, and LC-000143.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The products were shipped to medical facilities and sales representatives nationwide. The product was also shipped to distributors in the United Kingdom, France, Scotland, Belgium, Germany, Israel, Italy, Japan, Spain, Portugal, and Sweden.
  • Product Description
    SurgAssist System Circular Stapler DLU 29mm
  • Manufacturer
  • Model / Serial
    Product Code CS33, Lot numbers LC-000134, LC-000135, LC-000136, LC-000140, and LC-000144.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The products were shipped to medical facilities and sales representatives nationwide. The product was also shipped to distributors in the United Kingdom, France, Scotland, Belgium, Germany, Israel, Italy, Japan, Spain, Portugal, and Sweden.
  • Product Description
    SurgAssist System Circular Stapler DLU 33mm
  • Manufacturer