BEUDAMED
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    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.

    FDA Enforcement
    Class II ·Terminated·OrthoPediatrics Corp·November 28, 2012

    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.

    FDA Enforcement
    Class II ·Terminated·OrthoPediatrics Corp·November 14, 2012

    OrthoPediatrics PediLoc Locking Plate System, 4.5mm Contour Locking Compression Femur 8 Hole Plate Right. Used for pediatric patients as indicated for pelvic, small and long bone fractures.

    FDA Enforcement
    Class II ·Terminated·OrthoPediatrics Corp·August 1, 2012

    Response 5.5/6.0 Spine System 7.0mm x 40mm Pedicle Screw Product Usage: Posterior non-cervical pedicle screw fixation

    FDA Enforcement
    Class II ·Terminated·OrthoPediatrics Corp·February 21, 2018

    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.

    FDA Enforcement
    Class II ·Terminated·OrthoPediatrics Corp·February 12, 2014

    3.5mm Bowed Locking Compression Femur Plates, 14 hole Orthopediatrics PediLoc Locking Plate System comes in sets that offer the advantage of both conventional and locking plate fixation devices and instrumentation in one system. Utilizing both locking and non- locking screws, PediLoc offers a construct that resists angular collapse while simultaneously acting as an effective aid to fracture reduction.

    FDA Enforcement
    Class II ·Terminated·OrthoPediatrics Corp·September 28, 2016

    3.5mm Bowed Locking Compression Femur Plates, 18 hole Orthopediatrics PediLoc Locking Plate System comes in sets that offer the advantage of both conventional and locking plate fixation devices and instrumentation in one system. Utilizing both locking and non- locking screws, PediLoc offers a construct that resists angular collapse while simultaneously acting as an effective aid to fracture reduction.

    FDA Enforcement
    Class II ·Terminated·OrthoPediatrics Corp·September 28, 2016

    OrthoPediatrics ACL Reconstruction System ShieldLoc 6mm implant component model number 10-1008-4060 - Product Usage: is intended for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.

    FDA Enforcement
    Class II ·Terminated·OrthoPediatrics Corp·July 15, 2020

    OrthoPediatrics ACL Reconstruction System ShieldLoc 7mm implant component model number 10-1008-4070 - Product Usage: is intended for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.

    FDA Enforcement
    Class II ·Terminated·OrthoPediatrics Corp·July 15, 2020

    3.5MM LOCKING SCREW, T15 HEXALOBE, SELF TAPPING, 34MM The OrthoPediatrics Proximal Femur Plating System combines implants and instruments in one convenient system. This system offers the advantages of the osteotomy blade plates and cannulated instrumentation. Osteotomy plates provide ease of reduction and good rotational stability while maintaining bone stock. Cannulated instruments work over a guide wire for precise placement and safety. The subject device is a Bone Screw designed for use with this system.

    FDA Enforcement
    Class II ·Terminated·OrthoPediatrics Corp·November 20, 2013

    Model No. 01-1503-0032 (Adolescent Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic implant system commonly referred to as an intramedullary fixation rod (product code HSB). The attachment bolts are one component of the surgical instruments within the system.

    FDA Enforcement
    Class II ·Terminated·OrthoPediatrics Corp·November 6, 2019

    Model No. 01-1501-0032 (Child Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic implant system commonly referred to as an intramedullary fixation rod (product code HSB). The attachment bolts are one component of the surgical instruments within the system.

    FDA Enforcement
    Class II ·Terminated·OrthoPediatrics Corp·November 6, 2019

    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.

    FDA Enforcement
    Class II ·Terminated·OrthoPediatrics Corp·September 10, 2014

    3.2mm Drill Bit. This is a component within the PediLoc Locking Plate System utilized to pre-drill a hole in bone prior to placement of a bone screw.

    FDA Enforcement
    Class II ·Terminated·OrthoPediatrics Corp·August 21, 2013

    90 Degree Cannulated Infant Blade Plate 30mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking Cannulated Blade Plate System is intended for fixation of long bone fractures and osteotomies in all pediatric subgroups (except neonates) and in small stature adults. Specific indications include: intertrochanteric derotation and varus osteotomies, femoral neck and pertrochanteric fractures, intertrochanteric valgus osteotomies, proximal and distal tibial osteotomies and humeral fractures and osteotomies.

    FDA Enforcement
    Class II ·Terminated·OrthoPediatrics Corp·June 19, 2013

    90 Degree Cannulated Infant Blade Plate 35mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking Cannulated Blade Plate System is intended for fixation of long bone fractures and osteotomies in all pediatric subgroups (except neonates) and in small stature adults. Specific indications include: intertrochanteric derotation and varus osteotomies, femoral neck and pertrochanteric fractures, intertrochanteric valgus osteotomies, proximal and distal tibial osteotomies and humeral fractures and osteotomies.

    FDA Enforcement
    Class II ·Terminated·OrthoPediatrics Corp·June 19, 2013

    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.

    FDA Enforcement
    Class II ·Terminated·OrthoPediatrics Corp·January 1, 2014

    UniAxial Pedicle Screw & UniAxial Reduction Pedicle Screw The Response 5.5/6.0 Spine System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.

    FDA Enforcement
    Class II ·Terminated·OrthoPediatrics Corp·January 20, 2016

    Response BandLoc 5.5/6.0 Tensioner Instrument The Tensioner Instrument (01-1102-1000) is utilized to allow the surgeon to apply a recommended tension to the band and hold it in place during spine manipulation and set screw tightening.

    FDA Enforcement
    Class II ·Terminated·OrthoPediatrics Corp·June 14, 2017

    3.5mm Non Locking Cortical Screw, in the PediLoc Tibial Plate System Part number 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw. Used in pediatric orthopedics.

    FDA Enforcement
    Class II ·Terminated·OrthoPediatrics Corp·September 30, 2015