Device Recall GAP ENDOEXO MEDULLARY SYSTEM

  • Modelo / Serial
    Lot numbers: 110913-001; 110913-002; 110913-004; 110913-005;
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US Nationwide Distribution in the states of: California, Florida, New York, and Puerto Rico (US).
  • Descripción del producto
    GAP Nail 4.8mm (diameter size) of the GAP ENDO-EXO MEDULLARY SYSTEM. Catalog number GAP-N48-16; GAP-N48-18; GAP-N48-26; GAP-N48-28. || Product Usage: || The GAP Endo-Exo Medullary System is used for the treatment of fractures or correction of deformities in the femur, tibia and humerus of pediatric patients, who have reached skeletal maturity. The GAP Nail is an intramedullary nail. It is the main component of the GAP Endo-Exo Medullary System. The rest of the components of the system are screws, plates and caps that are assembled to the nail during the surgical procedure. The GAP Endo-Exo Medullary System is indicated as a temporary implant to assure alignment, stabilization and fixation of: long bones that have been surgically prepared (osteotomy) for correction of deformities or fractures caused by trauma or disease. The GAP System is used for pediatric patients (child and adolescent) ages 2 to 21. It can be used to correct the following conditions: -Diaphyseal fracture of the femur, tibia and humerus -Fractures of the femoral neck -Subtrochanteric, intertrochanteric and combination fractures -Correction of deformities (OI, Coxa vara, Coxa valga) -Nonunions and malunions
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Pega Medical Inc., 1111 Autoroute Chomedy, Laval Canada
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA