OrthoPediatrics Corp

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Description

18 dispositivos en la base de datos

  • Modelo / Serial
    Part number: 01-1050-0066 and 01-1050-0067 Lot numbers: 7861001 and 7861101 only
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution-including the states of OH, NC, CO, FL, IN, MI, and TX.
  • Descripción del producto
    4.5mm PLEO Osteotomy Guide. || OrthoPediatrics Corp. markets a pediatric, extension osteotomy bone plate system. This system is marketed under the brand name OrthoPediatrics PediLock Extension Osteotomy Plate ( PLEO ). The product included in this recall is a Class I, 4.5mm PLEO Osteotomy Guide Instrument, common name: Guide, Surgical, Instrument. The PediLoc¿ Extension Osteotomy Plate is part of the OrthoPediatrics~PediLoc¿ system. The PediLoc¿ Extension Osteotomy Plate consists of 3.5mm and 4.5mm plates, left and right side specific. The PediLoc¿ Extension Osteotomy Plate is designed to fit the anatomy of the distal femur in children and adolescents, above the distal femoral physis. The distal section of the plate is designed so that three locking screws can be placed in the distal bone segment at an angle parallel to the distal femoral physis. The proximal portion of the plate is designed to accept locking or non-locking screws. The subject instrument of this recall is an adjunct instrument for the convenience of some surgeons who choose to use it. This instrument is not illustrated in the Surgical Technique, nor required to perform the procedure.
  • Modelo / Serial
    Part number: 01-1500-9014 and Lot #'s 1466707 and 1466710
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution including AL, IL, NY, FL, TX, MI, KY, NC, CO, and GA.
  • Descripción del producto
    Trochar Scalpel Instrument (Surgical Punch) || OrthoPediatrics intramedullary rods (nails) are generally rod-shaped devices, with screw holes at either end for fixation to bone. This device is intended to be inserted into the medullary canal of the femur for fixation of fractures by aligning and stabilizing the bone fragments. Additional stabilization may be realized by installing transverse screws through holes in the rod. These devices are made of medical grade stainless steel. The OrthoPediatrics PediNail" system is used for pediatric and small stature adult patients as indicated to stabilize fractures of the femoral shaft; subtrochanteric fractures; ipsilateral neck/shaft fractures; prophylactic nailing of impending pathologic fractures; nonunions and malunions; fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity.
  • Modelo / Serial
    Part #: Lot Code: 01-1008-0040 132762 01-1008-0041 F132764, F132763 01-1008-0042 F132763, F132764 01-1008-0043 F132765, F132766 01-1008-0044 F132766, F132765 01-1008-0045 F132768 01-1008-0046 F132769 01-1008-0047 F132770
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US Nationwide Distribution.
  • Descripción del producto
    ACL Sleeve Installation Tool Sizes: 6mm, 6.5mm, 7.0mm, 7.5mm, 8.0mm, 8.5mm, 9.0mm, 10.0mm || Product Usage: || The OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system that offers both the fixation devices and instrument in one system. The insertion tool is used with a mallet to tap the tunnel sleeve implant into a counter-bored hole in the bone.
  • Modelo / Serial
    Lot 009SV
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA including OK, KY, FL, LA, OH, CO, MO, MN and Internationally to Ireland, Saudi Arabia, Italy, Turkey, South Africa, and Germany.
  • Descripción del producto
    3.5mm Locking Cortical Bone Screw, T15 Hexalobe, Self Tapping, 20mm || Part No. 00-0903-2620 || OrthoPediatrics Pediloc" Tibia Plates are indicated for fractures, osteotomies, and non-unions of the pediatric and small stature adult tibia. The subject recalled device is a Bone Screw designed for use with this system.
  • Modelo / Serial
    Part 01-1008-0040/0047 Lot 132762, F132763, F132764, F132765, F132766, F132768, F132769, F132770
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution including the states of CA, KY, OH, RI, and TN.
  • Descripción del producto
    OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system containing Sleeve Installation Tool Set , Part 01-1008-0040/0047, 6mm; 6.5mm, 7mm, 7.5mm, 8mm, 8.5mm, 9mm, and 10mm. || Used with ACL reconstruction system associated surgery.
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Más información acerca de la data acá

  • Dirección del fabricante
    Orthopediatrics Corp, 210 N Buffalo St, Warsaw IN 46580-2730
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA
  • Source
    RLMPH