Device Recall Orthopedic Alliance Spine System (alias "Blue & Gold")

  • Modelo / Serial
    All lots are being recalled.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Distributed in Texas.
  • Descripción del producto
    Orthopedic Alliance Spine System (alias "Blue & Gold") || Part Numbers: || BGC3010 Screw Cap || BGR0040 Straight Rod 5.5 x 40mm || BGR0050 Straight Rod 5.5 x 50mm || BGR0060 Straight Rod 5.5 x 60mm || BGR0070 Straight Rod 5.5 x 70mm || BGR0080 Straight Rod 5.5 x 80mm || BGR0090 Straight Rod 5.5 x 90mm || BGR0100 Straight Rod 5.5 x 100mm || BGR0110 Straight Rod 5.5 x 110mm || BGR0120 Straight Rod 5.5 x 120mm || BGR0130 Straight Rod 5.5 x 130mm || BGR0140 Straight Rod 5.5 x 140mm || BGR0150 Straight Rod 5.5 x 150mm || BGR0200 Straight Rod 5.5 x 200mm || BGR0300 Straight Rod 5.5 x 300mm || BGR0400 Straight Rod 5.5 x 400mm || BGR0500 Straight Rod 5.5 x 500mm || BGS5535 5.5 x 35mm Polyaxial Screw || BGS5540 5.5 x 40mm Polyaxial Screw || BGS5545 5.5 x 45mm Polyaxial Screw || BGS6035 6.0 x 35mm Polyaxial Screw || BGS6040 6.0 x 40mm Polyaxial Screw || BGS6045 6.0 x 45mm Polyaxial Screw || BGS6050 6.0 x 50mm Polyaxial Screw || BGS6535 6.5 x 35mm Polyaxial Screw || BGS6540 6.5 x 40mm Polyaxial Screw || BGS6545 6.5 x 45mm Polyaxial Screw || BGS6550 6.5 x 50mm Polyaxial Screw || BGS7035 7.0 x 35mm Polyaxial Screw || BGS7040 7.0 x 40mm Polyaxial Screw || BGS7045 7.0 x 45mm Polyaxial Screw || BGS7050 7.0 x 50mm Polyaxial Screw || BGS7055 7.0 x 55mm Polyaxial Screw || BGS7535 7.5 x 35mm Polyaxial Screw || BGS7540 7.5 x 40mm Polyaxial Screw || BGS7545 7.5 x 45mm Polyaxial Screw || A pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Orthopedic Alliance LLC, 26157 Jefferson Ave, Murrieta CA 92562-9561
  • Source
    USFDA