BEUDAMED
    257 results · 11ms · Sources: EU EUDAMED, US FDA

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    02.122.555S, 55mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults.

    FDA Recall
    Terminated ·Synthes USA (HQ), Inc.·October 27, 2010

    NFlex Straight monosegmental L 150mm The Synthes N-Hance and NFix II rods are intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the spine.

    FDA Recall
    Terminated ·Synthes USA (HQ), Inc.·Product code NQP·February 9, 2009

    NFix II System 150mm The Synthes N-Hance and NFix II rods are intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the spine.

    FDA Recall
    Terminated ·Synthes USA (HQ), Inc.·Product code NQP·February 9, 2009

    Synthes USA, TI Synex (TM) II Central Body 84mm - 110mm, Catalog number 04.808.010. Intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma. To be used with Synthes supplemental internal fixation system.

    FDA Recall
    Terminated ·Synthes USA (HQ), Inc.·Product code MQP·September 14, 2009

    Synthes USA, TI Synex (TM) II Central Body 37mm - 52mm, Catalog number 04.808.006. Intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma. To be used with Synthes supplemental internal fixation system.

    FDA Recall
    Terminated ·Synthes USA (HQ), Inc.·Product code MQP·September 14, 2009

    02.122.586S, 85mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults.

    FDA Recall
    Terminated ·Synthes USA (HQ), Inc.·Product code KTW·October 27, 2010

    02.122.585, 85mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults.

    FDA Recall
    Terminated ·Synthes USA (HQ), Inc.·Product code KTW·October 27, 2010

    02.122.580S, 80mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate SystemFor fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults.

    FDA Recall
    Terminated ·Synthes USA (HQ), Inc.·Product code KTW·October 27, 2010

    Synthes Spine T-PAL Spacer System. Transforaminal posterior atraumatic lumbar spacer system. Transforaminal posterior atraumatic lumbar spacer system. Synthes T-PAL Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the T-PAL Spacer should be packed with autogeneous bone graft (i.e. autograft). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

    FDA Recall
    Terminated ·Synthes USA (HQ), Inc.·Product code MAX·September 23, 2011

    Synthes Cannulated Distal Femoral Nail (Trauma Nail), Part Number 450.851S, 420MM-Sterile. Orthppedic implant device.

    FDA Recall
    Terminated ·Synthes USA HQ, Inc.·Product code HTY·April 18, 2013

    2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM Fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone.

    FDA Recall
    Terminated ·Synthes USA HQ, Inc.·Product code HRS·July 31, 2013

    Synthes Multi-Vector Distractor Body, Part Number 487.931. For mandibular bone lengthening.

    FDA Recall
    Terminated ·Synthes USA HQ, Inc.·Product code DZL·January 11, 2013

    Synthes Tensioning Device The Synthes Osteogenesis System, MR Conditional is intended for fracture fixation (open and closed), pseudoarthrosis or non-unions of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformities and correction of segmental bony or soft tissue defects in adult and pediatric patients.

    FDA Recall
    Terminated ·Synthes USA HQ, Inc.·Product code LXH·July 31, 2013

    Synthes Trochanteric Fixation Nail As part of the Synthes Trochanteric Fixation Nail (TFN) System, the TFN Nail is intended to treat stable and unstable fractures of the proximal femur.

    FDA Recall
    Terminated ·Synthes USA HQ, Inc.·Product code HSB·July 30, 2013

    Synthes USA, TI Synex (TM) II Central Body 58mm - 84mm, Catalog number 04.808.008. Intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma. To be used with Synthes supplemental internal fixation system.

    FDA Recall
    Terminated ·Synthes USA (HQ), Inc.·Product code MQP·September 14, 2009

    Synthes Titanium Minimally Invasive Reduction Screw System Locking Cap, Part Number 04.631.502 Non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation.

    FDA Recall
    Terminated ·Synthes USA HQ, Inc.·Product code NKB·September 7, 2012

    Large Buttress Compression Nut For Blade Guide Sleeve TFN The Synthes Large Buttress Compression Nut For Blade Guide Sleeve TFN is intended to treat stable and unstable pertrochanteric fractures, intertrochanteric fractures, basal neck fractures, and combinations there of.

    FDA Recall
    Terminated ·Synthes USA HQ, Inc.·Product code HSB·July 31, 2013

    Synthes Soft Tissue Retractor Small Extendible Offset blade facilitates easy preparation of the epipereosteal cavity for percutaneous plate insertion.

    FDA Recall
    Terminated ·Synthes USA HQ, Inc.·Product code GAD·September 24, 2013

    Synthes(R) Hemostatic Bone Putty, Part numbers 08.901.001.97S, 08.901.001.98S, 08.901.001.99S, 08.901.001D, and VB1025.10S. Indicated for use as a water soluble implant material and for use in the control of bleeding from bone surfaces.

    FDA Recall
    Terminated ·Synthes USA HQ, Inc.·Product code MTJ·July 5, 2012

    MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).

    FDA Recall
    Terminated ·Synthes USA HQ, Inc.·Product code NKB·June 18, 2012