BEUDAMED
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    Pega Medical Inc., Fassier-Duval IM Telescopic System, male component (solid shaft), Part number: M040-SS-110; Used in Implant Catalogue number: FD-040(LS)-SS. orthopedic intramedullary rod.

    FDA Enforcement
    Class II ·Terminated·Pega Medical Inc.·April 16, 2014

    Pega Medical Inc., Fassier-Duval IM Telescopic System, male component (solid shaft), Part number: M040-SS-110; Used in Implant Catalogue number: FD-040(LS)-SS. orthopedic intramedullary rod.

    FDA Recall
    Terminated ·Pega Medical Inc. 1111 Autoroute Chomedy Laval Canada·Product code HSB·February 7, 2014

    Slipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE Screw System with catalogue number SCF-MLD265 and SCF-MLD273.

    FDA Recall
    Terminated ·Pega Medical Inc. 1111 Autoroute Chomedy Laval Canada·Product code HWC·June 15, 2015

    Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medullary (SLIM) System - Product Usage: The SLIM handle is the grip for the SLIM driver in orthopedic surgical procedures.

    FDA Recall
    Terminated ·Pega Medical Inc. 1111 Chomedey (A-13) E Laval Canada·Product code LXH·April 3, 2020

    SLIM Handle - catalogue #: SLM-HND100 a component of Simple Locking Intramedullary (SLIM) System

    FDA Recall
    Terminated ·Pega Medical Inc. 1111 Chomedey (A-13) E Laval Canada·Product code HSB·May 29, 2019

    SCFE Driver (SCF-MLD273 & SCF-MLD265) instrument used for the insertion of the Free Gliding SCFE Screw System. This instrument is included in the Free Gliding SCFE Screw System instrument tray. This instrument is marked with the catalogue number and lot number. The Free-Gliding SCFE Screw System is a temporary implant for stabilization of pediatric femoral neck fractures and slipped capital femoral epiphysis (SCFE) in pediatric patients. Orthopedic.

    FDA Enforcement
    Class II ·Terminated·Pega Medical Inc.·December 2, 2015

    Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. Catalogue number FD-040(L)-SS. -Duval IM Telescopic System.

    FDA Enforcement
    Class II ·Terminated·Pega Medical Inc.·April 30, 2014

    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

    FDA Enforcement
    Class II ·Terminated·Pega Medical Inc.·April 8, 2015

    Female Driver, Part number FDr101, instrument used for the insertion of the Fassier-Duval IM Telescopic System. For orthopedic procedures. This instrument is included in the Fassier-Duval IM Telescopic System instrument tray. This instrument is marked with the catalogue number and lot number.

    FDA Enforcement
    Class II ·Terminated·Pega Medical Inc.·May 6, 2015

    Slipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE Screw System with catalogue number SCF-MLD265 and SCF-MLD273.

    FDA Enforcement
    Class II ·Terminated·Pega Medical Inc.·July 8, 2015

    SLIM Handle - catalogue #: SLM-HND100 a component of Simple Locking Intramedullary (SLIM) System

    FDA Enforcement
    Class II ·Terminated·Pega Medical Inc.·August 21, 2019

    SCFE (slipped capital femoral epiphysis) Knobs for Driver, 6.5mm and 7.3 mm Orthopedic surgical instrument component, for hip surgery

    FDA Enforcement
    Class II ·Terminated·Pega Medical Inc.·November 13, 2019

    Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medullary (SLIM) System - Product Usage: The SLIM handle is the grip for the SLIM driver in orthopedic surgical procedures.

    FDA Enforcement
    Class III ·Terminated·Pega Medical Inc.·May 27, 2020

    Female Driver, Part number FDr101, instrument used for the insertion of the Fassier-Duval IM Telescopic System. For orthopedic procedures. This instrument is included in the Fassier-Duval IM Telescopic System instrument tray. This instrument is marked with the catalogue number and lot number.

    FDA Recall
    Terminated ·Pega Medical Inc. 1111 Autoroute Chomedy Laval Canada·Product code HSB·April 10, 2015

    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

    FDA Recall
    Terminated ·Pega Medical Inc. 1111 Autoroute Chomedy Laval Canada·Product code HSB·February 20, 2015

    SCFE Driver (SCF-MLD273 & SCF-MLD265) instrument used for the insertion of the Free Gliding SCFE Screw System. This instrument is included in the Free Gliding SCFE Screw System instrument tray. This instrument is marked with the catalogue number and lot number. The Free-Gliding SCFE Screw System is a temporary implant for stabilization of pediatric femoral neck fractures and slipped capital femoral epiphysis (SCFE) in pediatric patients. Orthopedic.

    FDA Recall
    Terminated ·Pega Medical Inc. 1111 Autoroute Chomedy Laval Canada·Product code HWC·October 20, 2015

    Male Driver 4.0mm (catalog # MDr140L) and Male Driver 3.2mm (catalog # MDr132L), an instrument used for the insertion of the Fassier-Duval Telescopic IM System intramedullary nail, for bone fixation.

    FDA Recall
    Terminated ·Pega Medical Inc. 1105 Autoroute Chomedy Laval Canada·Product code HSB·January 29, 2010

    Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. Catalogue number FD-040(L)-SS. -Duval IM Telescopic System.

    FDA Recall
    Terminated ·Pega Medical Inc. 1111 Autoroute Chomedy Laval Canada·Product code HSB·March 5, 2014

    SCFE (slipped capital femoral epiphysis) Knobs for Driver, 6.5mm and 7.3 mm Orthopedic surgical instrument component, for hip surgery

    FDA Recall
    Terminated ·Pega Medical Inc. 1111 Chomedey (A-13) E Laval Canada·Product code LXH·October 2, 2019