Device Recall Timberline MPF Straight Split Tip Driver Short ("Driver")

  • Modelo / Serial
    Lot No: TU00090, TU00157 and TU00242
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution including AZ, PA, WI, NY, TX, PR, and TN.
  • Descripción del producto
    LANX Timberline MPF Lateral Modular Plate Fixation System Straight Split Tip Driver - Short ("Driver"). Model Number 8630-0107. || The Timberline MPF device is an intervertebral body fusion device consisting of a PEEK intervertebral spacer, titanium plate, and screws. The PEEK spacer has a generally rounded shape with various heights and footprints and has a hollowed out central area to accommodate autogenous bone graft. The upper and lower surfaces have a series of transverse grooves formed to improve stability and fixation once the device is inserted. The titanium plate has holes for receiving bone screws and a central hole for receiving a cover plate to prevent screw back-out. The Timberline MPF system is available in a variety of sizes and configurations to approximate anatomical variation in different vertebral levels and/or patient anatomy. The Timberline MPF system is provided nonsterile. The Driver is used with the Timberline MPF system to drive titanium screws through the plate and into the vertebrae thus locking plate to the vertebrae.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Lanx, Inc., 310 Interlocken Pkwy Ste 120, Broomfield CO 80021-3464
  • Source
    USFDA