Device Recall The ECHELON 60 Endoscopic Linear Cutter

  • Model / Serial
    Model # EC60: H44T06, J4A56P, J4A67X, H44T6E, J4A650, J4A762, J4A49A, J4A65N, J4A766, J4A49G, J4A677, J4A76F, J4A567, J4A67D, J4A76L, J4A56F, J4A67H, J4A771; Model # LONG60 lots: H44R8A , H44U3R , H44X17 , J4A55E , J4A64A; Model # SC60: H44R6C, J4A777, J4A58D, J4A77F, J4A58N, J4A78Y, J4A58P.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA including AL, AR, CA, CO, FL, IA, IL, KS, LA, MD, MO, MS, NC, NM, NY, OH, SC, TX & VA; and the countries of Argentina, Ecuador, Mexico, Australia, Egypt, Singapore, Belgium, Greece, Slovenia, Brazil, India, South Africa, China, Israel, United Arab Emirates, Colombia, Japan & Venezuela.
  • Product Description
    The ECHELON 60 Endoscopic Linear Cutter - Straight, compact ECHELON 60 Endoscopic Linear Cutter - Straight, and the Long ECHELON 60 Endoscopic Linear Cutter - Straight are sterile, single patient use instruments that deliver staples while simultaneously dividing tissue between rows. ECHELON 60 instruments with white, blue, gold, and green reloads deliver two triple-staggered rows of staples. The instruments have a staple line that is approximately 60 mm long and a cut line that is approximately 57 mm long. A staple retaining cap on the reload protects the staple leg points during || shipping and transportation. Sterile products are individually packed in a transparent tray sealed with Tyvek¿. Each tray is placed in an individual carton. 3 individual cartons are placed in a corrugated shipper. || The ECHELON 60 Endoscopic Linear Cutter  Straight, Compact ECHELON 60 Endoscopic Linear Cutter  Straight, and the Long ECHELON 60 Endoscopic Linear Cutter  Straight are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing materials.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Ethicon Endo-Surgery Inc, 4545 Creek Rd, Cincinnati OH 45242-2803
  • Manufacturer Parent Company (2017)
  • Source
    USFDA