BEUDAMED
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    INTEGRA LIFE SCIENCES

    FDA Adverse Event
    Malfunction ·INTEGRA LIFE SCIENCES·Product code JXG·November 21, 2008

    CERTAS CODMAN

    FDA Adverse Event
    Malfunction ·JOHNSON & JOHNSON / INTEGRA LIFESCIENCES·Product code JXG·November 19, 2018

    INTEGRA TOTAL FOOT SYSTEM II

    FDA Adverse Event
    Malfunction ·INTEGRA LIFESCIENCES CORPORATION·Product code HRS·July 13, 2016

    MAYFIELD MODIFIED SKULL CLAMP

    FDA Adverse Event
    Malfunction ·Product code HBL·November 24, 2009

    HALLU- FIX ABLATION SET

    FDA Adverse Event
    Injury ·NEWDEAL SAS·Product code HWC·June 5, 2018

    HALLUFIX PLATE, UNKNOWN

    FDA Adverse Event
    Injury ·NEWDEAL SAS·Product code HTW·June 5, 2018

    RADIONICS EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·RADIONICS·Product code JXG·June 27, 2003

    RANEY CLIPS

    FDA Adverse Event
    Malfunction ·CODMAN & SHURTLEFF, INC.·Product code GDO·August 11, 2020

    MAYFIELD MODIFIED SKULL CLAMP

    FDA Adverse Event
    Other ·Product code HBL·December 3, 2009

    MEDIHONEY GEL AND DRESSING

    FDA Adverse Event
    Injury ·INTEGRA LIFE SCIENCES CORPORATION·Product code FRO·July 21, 2020

    INTEGRA LIFE SCIENCES DURAGEN BOVINE PERICARDIUM GRAFT

    FDA Adverse Event
    Injury ·INTEGRA LIFESCIENCES CORPORATION·Product code GXQ·April 21, 2025

    10 ML SPRAYSHIELD KIT AND AIR ASSISTED SPRAYER STERILE SINGLE USE 1

    FDA Adverse Event
    Malfunction ·INTEGRA LIFESCIENCES HOLDING CORPORATION·Product code NQR·August 29, 2014

    UNK

    FDA Adverse Event
    Malfunction ·INTEGRA NEUROSCIENCES IMPLANTS S.A.·Product code JXG·January 19, 2006

    The 2.7mm Drilling Guide is a reusable instrument used in conjunction with a drill to prepare oriented holes in bone for insertion of a Standard Surfix Locking Screw with plates for the Tiblaxis, Uni-CP, Advansys MLP and Advansys DLP compression plate systems. The Drilling Guides are initially supplied to users in kits containing the devices that comprise the Tibiaxis, Uni-CP, Advansys MLP and Advansys DLP systems. Should the Drilling Guides need to be replaced, they can be replenished by the customer placing an order. The replacement is shipped to the customer in sealed plastic bags. Uni-CP" Compression Plate The Uni-CP" Compression Plate is indicated for fixation of bone fractures or for bone reconstruction: - Arthrodesis in foot and ankle surgery - Fracture management in the foot and ankle - Mono or bi-cortical osteotomies in the foot and ankle TIBIAXYS" Plates The Newdeal TIBIAXYS" Plates are indicated For fixation of bone fractures or for bone reconstruction. Examples include Osteotomies and fractures of ankle joint, distal tibia and fibula. The Newdeal TIBIAXYS" Plates must be fixed with the Newdeal Surfix 3.5mm diameter fixation screws and lock-screws. ADVANSYS Mid-Foot Plating System: Dorsal Lisfranc Plate (DLP) and Medical Lisfranc Plate (MLP) The Dorsal Lisfranc Plates are intended for fractures, fusions, osteotomies and replantations of small bones at the tarsometatarsal joints The Medial Lisfranc Plates are intended for bone fixation such as: arthrodesis of the 1st metatarsocuneiform joint to reposition and stabilize a metatarsus primus varus: - Lisfranc arthrodesis - Mono or bi-cortical osteotomies or fractures near the 1st metatarsocuneiform joint

    FDA Recall
    Terminated ·Integra Life Sci.·Product code FZX·June 14, 2012

    MAYFIELD MODIFIED SKULL CLAMP

    FDA Adverse Event
    Other ·INTEGRA-OHIO·Product code HBL·November 30, 2009

    MAYFIELD MODIFIED SKULL CLAMP

    FDA Adverse Event
    Malfunction ·INTEGRA LIFESCIENCES CORPORATION·Product code HBL·March 25, 2008

    MAYFIELD MODIFIED SKULL CLAMP

    FDA Adverse Event
    Malfunction ·INTEGRA LIFESCIENCES CORPORATION·Product code HBL·March 25, 2008

    The 2.7mm Drilling Guide is a reusable instrument used in conjunction with a drill to prepare oriented holes in bone for insertion of a Standard Surfix¿ Locking Screw with plates for the Tiblaxis, Uni-CP, Advansys MLP and Advansys DLP compression plate systems. The Drilling Guides are initially supplied to users in kits containing the devices that comprise the Tibiaxis, Uni-CP, Advansys MLP and Advansys DLP systems. Should the Drilling Guides need to be replaced, they can be replenished by the customer placing an order. The replacement is shipped to the customer in sealed plastic bags. Uni-CP" Compression Plate The Uni-CP" Compression Plate is indicated for fixation of bone fractures or for bone reconstruction: - Arthrodesis in foot and ankle surgery - Fracture management in the foot and ankle - Mono or bi-cortical osteotomies in the foot and ankle TIBIAXYS" Plates The Newdeal¿ TIBIAXYS" Plates are indicated For fixation of bone fractures or for bone reconstruction. Examples include Osteotomies and fractures of ankle joint, distal tibia and fibula. The Newdeal¿ TIBIAXYS" Plates must be fixed with the Newdeal Surfix¿ 3.5mm diameter fixation screws and lock-screws. ADVANSYS¿ Mid-Foot Plating System: Dorsal Lisfranc Plate (DLP) and Medical Lisfranc Plate (MLP) The Dorsal Lisfranc Plates are intended for fractures, fusions, osteotomies and replantations of small bones at the tarsometatarsal joints The Medial Lisfranc Plates are intended for bone fixation such as: arthrodesis of the 1st metatarsocuneiform joint to reposition and stabilize a metatarsus primus varus: - Lisfranc arthrodesis - Mono or bi-cortical osteotomies or fractures near the 1st metatarsocuneiform joint

    FDA Enforcement
    Class II ·Terminated·Integra Life Sci.·September 26, 2012

    OSVII, CONNECTOR WITH ANTECHAMBER

    FDA Adverse Event
    Malfunction ·INTEGRA NEUROSCIENCES IMPLANTS S.A.·Product code JXG·December 9, 2011

    ENDOWRIST

    FDA Adverse Event
    INTUITIVE SURGICAL, INC.·Product code NAY·January 27, 2015