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  • Dispositivo 18
  • Fabricante 16
  • Evento 124969
  • Implante 16
ILLICO cannulated polyaxial screws
  • Modelo / Serial
  • ¿Implante?
    Yes
  • Descripción del producto
    Non-active implants - bone surgery
  • Manufacturer
    ALPHATEC SPINE
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de ILLICO cannulated polyaxial screws
the Solus Anterior Lumbar Interbody Fusion Spinal Spacer System
  • Modelo / Serial
  • ¿Implante?
    Yes
  • Descripción del producto
    Non-active implants
  • Manufacturer
    ALPHATEC SPINE
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de the Solus Anterior Lumbar Interbody Fusion Spinal Spacer System
Device Recall IILICO MIS Posterior Spinal Fixation System
  • Modelo / Serial
    Lot # 635436; Part #73601-110
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA including CO and NC; Internationally to Belgium.
  • Descripción del producto
    ILLICO Straight CP TI Rod, -5.5MM x 110M; REF#73601-110; Qty 1; LBL-005; REV.B; RX ONLY; Alphatec Spine, Inc. The ILLICO¿ MIS Posterior Spinal Fixation System is intended to facilitate the surgical correction of non-cervical spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development.
  • Manufacturer
    Alphatec Spine, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall IILICO MIS Posterior Spinal Fixation System
Device Recall Novel Spinal Spacer System
  • Modelo / Serial
    Part Number(s): 64817-010 Lot Number(s): 623549; Part Number(s): 64817-012 Lot Number(s): 623551; Part Number(s): 64817-013 Lot Number(s): 623552; Part Number(s): 64817-014 Lot Number(s): 623553; Part Number(s): 64817-107 Lot Number(s): 623584; Part Number(s): 64113-012 Lot Number(s): 623619; Part Number(s): 64113-010 Lot Number(s): 623620; Part Number(s): 64765-109 Lot Number(s): 623909; and Part Number(s): 64733-124 Lot Number(s): 623778.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution -- CA, NV, FL, CT, TX, IA and WI.
  • Descripción del producto
    Alphatec Spine, Inc., NOVEL SPINAL SPACER SYSTEM, Part Number(s): 64817-010, 64817-012, 64817-013, 64817-014, 64817-107, 64113-012, 64113-010, 64765-109, 64733-124. || Spinal fixation system consisting of various shapes or varying sizes to accommodate individual patient pathology.
  • Manufacturer
    Alphatec Spine, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Novel Spinal Spacer System
Device Recall TRESTLE LUXE Anterior Cervical Plating System
  • Modelo / Serial
    Product code KWQ. 510(k) K102820 Part Number 71721. Lot numbers: 6629701, 6594701, 6434301, 6434302, 6434302R1.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    TRESTLE LUXE¿ Anterior Cervical Plating System, Product code KWQ. 510(k) K102820. || The TRESTLE LUXE Anterior Cervical Plating System is a temporary device used to stabilize the cervical spine during bone fusion development. Device implants include a range of plate sizes and bone screws to provide the versatility required for the specific indications noted. Fixation is achieved by means of a rigid plate that is surgically attached to the spine with bone screws. The TRESTLE LUXE Anterior Cervical Plating System is intended for use in the anterior cervical spine (C2-C7). Patients with trauma (including fractures), spondylolisthesis, and pseudoarthrosis, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, tumors, and failed previous fusion.
  • Manufacturer
    Alphatec Spine, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall TRESTLE LUXE Anterior Cervical Plating System
Device Recall Solanas 2.1mm FIXED DEPTH DRILL, 10mm
  • Modelo / Serial
    Lot No. 7117902
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution including CT, NC, AL, WV, IL, AR, and NY.
  • Descripción del producto
    Solanas 2.1mm FIXED DEPTH DRILL, 10mm, Part No. 63928-10. Component of the SOLANAS III Posterior Stabilization System, a spinal fixation system intended to improve stability of the cervical and thoracolumbar area of the spine (C1-T3).
  • Manufacturer
    Alphatec Spine, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Solanas 2.1mm FIXED DEPTH DRILL, 10mm
Device Recall lllico Ti Cannulated Polyaxial Screw
  • Modelo / Serial
    Part Number 73875-40. Lots Affected:  647289, 648923, 649244, 649556, 649813, 650040, 650262, 650589.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide distribution: US (nationwide) including states of:US states: AZ, CA, FL, GA, IL, MD, NJ, NY, OK, PA, TN, TX,and WA ; and countries of: Spain, France, Japan. International: Spain, France, Japan.
  • Descripción del producto
    Illico Ti Cannulated Polyaxial Screw 7.5mm X 40mm. The Illico MIS Posterior Fixation System is intended to facilitate the surgical correction of noncervical spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development.
  • Manufacturer
    Alphatec Spine, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall lllico Ti Cannulated Polyaxial Screw
Device Recall Leucadia Autolok" Polyaxial Pedicle Screw System
  • Modelo / Serial
    83010 85001 85002 83005-30  83005-35  83005-40  83005-45  83005-50  83006-30  83006-35  83006-40  83006-45  83006-50  83006-55  83006-60  83007-30  83007-35  83007-40  83007-45  83007-50  83007-55  83008-30  83008-35  83008-40  83008-45  83008-50  83008-55  83008-80  82001-1    Catalog Numbers: LA-HSS0010  LA-HDOO01  LA-CTOO02  LA-PS0530  LA-PS0535  LA-PS0540  LA-PS0545  LA-PS0550  LA-PS0630  LA-PS0635  LA-PS0640  LA-PS0645  LA-PS0650  LA-PS0655  LA-PS0660  LA-PS0730  LA-PS0735  LA-PS0740  LA-PS0745  LA-PS0750  LA-PS0755  LA-PS0830  LA-PS0835  LA-PS0840  LA-PS0845  LA-PS0850  LA-PS0855  LA-PS0880  LA-SOO01   Lots Affected: All
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    Leucadia Autolok" Polyaxial Pedicle Screw System. || Intended to help provide correction, immobilization and stabilization of spinal segments.
  • Manufacturer
    Alphatec Spine, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Leucadia Autolok" Polyaxial Pedicle Screw System
Device Recall Zodiac Pedicle Screw System
  • Modelo / Serial
    Lot # 634745
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution including TN, WI, and FL.
  • Descripción del producto
    TI Standard Polyaxial Screw Assembly 6.5MM x 55MM. Part # 62065-55. || Subsequent Product Codes: MNH, MNI. || The Zodiac Polyaxial Pedicle Screw System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies in the thoraco-lumbo-sacral portion of the spine. It intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the Zodiac Polyaxial Pedicle Screw System are dependent in part on the configuration of the assembled device and the method of attachment to the spine.
  • Manufacturer
    Alphatec Spine, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Zodiac Pedicle Screw System
Device Recall Alphatec Souls Proximal/Distal Deployment Wrench
  • Modelo / Serial
    Part Numbers: 25975 & 25976. Product Code(s): MAX. Market Clearance: 510(k) K102402.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA (nationwide) and Germany
  • Descripción del producto
    SOLUS Anterior Lumbar Interbody Fusion Spinal || Spacer System, Solus Proximal/Distal Deployment Wrenches, 510(k) K102402. || The Alphatec Solus Anterior Lumbar Interbody Fusion (AUF) System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DOD) at one or two contiguous levels from L2-S1 with up to Grade 1 spondyiolisthesis or retrolisthesis at the involved level(s). DOD 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. The Alphatec Solus implant is intended to be used with autograft. The device is intended for use with supplemental fixation that is in addition to the integrated blades. The Alphatec Solus implant is intended for use with supplemental spinal fixation. Specifically, the Alphatec Solus implant is to be used with the Alphatec's Zodiac¿ Spinal Fixation System, Aspida" Anterior Lumbar Plating System, or the ILLlCO¿ MIS Posterior Fixation System. Intervertebral body fusion device.
  • Manufacturer
    Alphatec Spine, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Alphatec Souls Proximal/Distal Deployment Wrench
Device Recall Solanas Posterior Stabilization System
  • Modelo / Serial
    Lot Numbers: 608227B, 609867B, 609870B, 609882B, 609897B, 609971B
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution-including the states of CA, CT, FL, GA, NC, NE, NJ, TX, and UT.
  • Descripción del producto
    Solanas Posterior Stabilization System Part Number: 63920. || Solanas Posterior Stabilization System facilitates the surgical correction of spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. The Solanas Posterior Stabilization System is a spinal fixation system intended to improve stability of the cervical and thoracolumbar area of the spine (C1-T3).
  • Manufacturer
    Alphatec Spine, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Solanas Posterior Stabilization System
Solanas
  • Modelo / Serial
    Lot Numbers: 624241, 624242, 625418
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide distribution.
  • Descripción del producto
    Alphatec Spine Solanas Titanium Pedicle Screw Part Number 63035-14
  • Manufacturer
    Alphatec Spine, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Solanas
Solanas
  • Modelo / Serial
    Lot Numbers: 624239, 624240
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide distribution.
  • Descripción del producto
    Alphatec Spine Solanas Titanium Pedicle Screw, Part Number 63035-12
  • Manufacturer
    Alphatec Spine, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Solanas
4.0mm Variable Angle, SelfDrilling Hexalobe Screw, 14mm
  • Modelo / Serial
    Part Number: 71240-14 Lot: 685904
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - US Distribution to the states of: KS, LA, TN, NJ, KY, CA, FL, OR, OK, AZ, WI, CO, IN, NH, AR, UT, and AL., and to the countries of : Spain, Japan, Belgium, and Saudi Arabia.
  • Descripción del producto
    4.0mm Variable Angle, Self-Drilling Hexalobe Screw, 14mm || Alphatec Spine || Solutions for the Aging Spine || Trestle Luxe Anterior Cervical Plating System || REF 71240-14 || LOT XXXXXX || Alphatec Spine, Inc. || EN: 4.0MM Variable Angle, Self--Drilling Hexalobe Screw, 14MM (TI-6AL-4V ELI) || NON STERILE || Single Use Only
  • Manufacturer
    Alphatec Spine, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de 4.0mm Variable Angle, SelfDrilling Hexalobe Screw, 14mm
Illico Ti Cannulated Polyaxial Screw
  • Modelo / Serial
    Product Codes: KW, MNI, MNH.  Part NumberlLot Number: ¿PART DESCRIPTION LOT  7384S-30 Ti CANNULATED POLYAXIAL SCREW 4.5mm X 30mm 646501  73845-35 Ti CANNULATED POLYAXIAL SCREW 4.5mm X 35mm 646502  73845-40 Ti CANNULATED POLYAXIAL SCREW 4.5mm X 40mm 646503  73845-45 Ti CANNULATED POLYAXIAL SCREW 4.5mm X 45mm 646504  73855-35 Ti CANNULATED POLYAXIAL SCREW 5.5mm X 35mm 646510  73865-30 Ti CANNULATED POLYAXIAL SCREW 6.5mm X 30mm 646515  73865-35 Ti CANNULATED POLYAXIAL SCREW 6.5mm X 35mm 646516  73865-40 Ti CANNULATED POLYAXIAL SCREW 6.5mm X 40mm 646517  73865-45 Ti CANNULATED POLYAXIAL SCREW 6.5mm X 45mm 646542  73865-50 Ti CANNULATED POLYAXIAL SCREW 6.5mm X 50mm 646543  73875-35 Ti CANNULATED POLYAXIAL SCREW 7.5mm X 35mm 646546  73875-45 Ti CANNULATED POLYAXIAL SCREW 7.5mm X 45mm 646548  73875-50 Ti CANNULATED POLYAXIAL SCREW 7.5mm X 50mm 646549
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution including AZ, IL, CA, SC, TN, TX, GA, CT, NY, FL, OK, LA, MO, NV,and UT.
  • Descripción del producto
    ILLlCO¿ MIS Posterior Fixation System, Bone-screw Internal Spinal Fixation System, || Orthosis, Spinal Pedical Fixation || Orthosis, Spondylolisthesis Spinal Fixation || The ILLICO MIS Posterior Fixation System is intended to facilitate the surgical correction of noncervical spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. When used for a minimally invasive posterior approach ILLlCO¿ MIS Instrumentation is used in conjunction with polyaxial screw components. The ILLICO MIS Posterior Fixation System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies of the spine. It is intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the ILLICO MIS Posterior Fixation System are dependent in part on the configuration of the assembled device and the method of attachment to the spine.
  • Manufacturer
    Alphatec Spine, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Illico Ti Cannulated Polyaxial Screw
Device Recall Trestle Anterior Cervical Plate
  • Modelo / Serial
    Lot Number: 5481103
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution -- AL, CA, FL, TN, TX and UT.
  • Descripción del producto
    Trestle Anterior Cervical Plate 1-level assembly, Part Number: 61001-026. Alphatec Spine, Carlsbad, CA 92008. || Intended for the temporary stabilization of the anterior spine during the development of fusion in patients.
  • Manufacturer
    Alphatec Spine, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Trestle Anterior Cervical Plate

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Los dispositivos médicos ayudan con el diagnóstico, la prevención y el tratamiento de muchas lesiones y enfermedades. A través de la International Medical Devices Database no estamos sugiriendo que compañías u otras entidades mencionadas en la base de datos hayan sido parte de una conducta ilegal o hayan actuado de manera impropia. Un mismo dispositivo médico puede tener distintos nombres en diferentes países. Esta base de datos no busca proporcionar asesoría médica. Los pacientes deben consultar con sus médicos para determinar si la data contiene información relevante y si la misma tiene implicaciones médicas para ellos.

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