Device Recall OsteoClage Stainless Steel Bone Plate

  • Modèle / numéro de série
    2.0mm x 80mm SS cable/sleeve: Lot # 222078, 232175, 245032, 254368, 261903, 270659, 284155, 297281.  2.0mm SS sleeve only: Lot # 247553, 267469, 280871, 313261.  8, 7 hole SS compression plate: Lot # 300381.  10, 9 hole SS compression plate: Lot # 299641.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Nationwide Distribution - in the states of CA, CO, FL, GA, LA, MI, MN, MO, OH, OR, PA, PR, TX, UT, VA, WA and WY. Product was distributed outside the US to: Australia, China, Figi, France, Great Britain, Italy, Japan, Korea, Maylasia, Sweden, South Africa, Spain.
  • Description du dispositif
    The Osteo-Clage System consists of stainless steel cable/sleeves and compression plates. . || 2.0 mm x 850mm SS Cable/Sleeve; Part Number 01-0020-S || 2.0 mm SS Sleeve Only; Part Number 01-0022-S || 8, 7 hole, SS compression plate; Part Number 02-2007-S || 10, 9 hole, SS compression plate; Part Number 02-2009-S || Product Usage: The Osteo-Clage Stainless Steel Bone Plate is an implantable straight, rigid stainless steel plate. It is used in conjunction with 4.5mm Cortical bone screws to provide compression across bone fractures. The Osteo-Clage Cerclage Wire Crimp sleeve is used in conjunction with the bone plate in cerclage fixation procedures
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Acumed LLC, 5885 NW Cornelius Pass Rd, Hillsboro OR 97124-9432
  • Société-mère du fabricant (2017)
  • Source
    USFDA