Device Recall ADVANCE TIBIAL WEDGE AUGMENT

  • Model / Serial
    Lot numbers: 087441267 and 097441268.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- United States, Canada, Netherlands, Germany, Japan, S. Korea, UK, Czech Republic, Turkey and Brazil.
  • Product Description
    ADVANCE TIBIAL WEDGE AUGMENT, REF KTAG-W315, SIZE 3/2+, Thickness 15 DEG, SURFACE NON-POROUS, 1 EACH, Wright Medical Technology, 4677 Airline Road, Arlington, TN 38002. || The device is intended for use in total knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions: 1) Noninflammatory degenerative joint disease, 2)inflammatory joint disease, 3) correction of functional deformity, 4) revision procedures where other treatments or devices have failed and 5) treatment of fractures that are unmanageable using other techniques. (For cement use only).
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Wright Medical Technology Inc, 5677 Airline Rd, Arlington TN 38002
  • Manufacturer Parent Company (2017)
  • Source
    USFDA