BEUDAMED
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    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.

    FDA Recall
    Terminated ·Alphatec Spine, Inc.·Product code MAX·May 13, 2009

    ROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC bolts/screws. Product is used to contain spinal implants.

    FDA Recall
    Terminated ·Alphatec Spine, Inc.·Product code LRP·December 16, 2008

    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.

    FDA Recall
    Terminated ·Alphatec Spine, Inc.·Product code KWQ·August 25, 2009

    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).

    FDA Recall
    Terminated ·Alphatec Spine, Inc.·Product code KWP·November 1, 2010

    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.

    FDA Recall
    Terminated ·Alphatec Spine, Inc.·Product code KWP·December 9, 2010

    Zodiac Polyaxial Spinal Fixation System. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.

    FDA Recall
    Terminated ·Alphatec Spine, Inc.·Product code KWP·November 3, 2008

    Atec Insignia Anterior Cervical Plate System, REF 136-0120, Insignia, ACP, 1-Level, 20 mm, Rx Only, Non-Sterile, UDI: (01)00190376268460

    FDA Recall
    Terminated ·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021

    Atec Insignia Anterior Cervical Plate System, REF 136-0468 Insignia, ACP, 4-Level, 68 mm, Rx Only, Non-Sterile, UDI: (01)00190376268675

    FDA Recall
    Terminated ·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021

    Atec Insignia Anterior Cervical Plate System, REF 136-0122, Insignia, ACP, 1-Level, 22 mm, Rx Only, Non-Sterile, UDI: (01)00190376268484

    FDA Recall
    Terminated ·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021

    Atec Insignia Anterior Cervical Plate System, REF 136-0362 Insignia, ACP, 3-Level, 62 mm, Rx Only, Non-Sterile, UDI: (01)00190376268620

    FDA Recall
    Terminated ·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021

    Atec Insignia Anterior Cervical Plate System, REF 136-0248 Insignia, ACP, 2-Level, 48 mm, Rx Only, Non-Sterile, UDI: (01)00190376268521

    FDA Recall
    Terminated ·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021

    Atec Insignia Anterior Cervical Plate System, REF 136-0240 Insignia, ACP, 2-Level, 40 mm, Rx Only, Non-Sterile, UDI: (01)00190376268408

    FDA Recall
    Terminated ·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021

    Atec Insignia Anterior Cervical Plate System, REF 136-0482 Insignia, ACP, 4-Level, 82 mm, Rx Only, Non-Sterile, UDI: (01)00190376268712

    FDA Recall
    Terminated ·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021

    Atec Insignia Anterior Cervical Plate System, REF 136-0116, Insignia, ACP, 1-Level, 16 mm, Rx Only, Non-Sterile, UDI: (01)00190376268422

    FDA Recall
    Terminated ·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021

    Atec Insignia Anterior Cervical Plate System, REF 136-0124, Insignia, ACP, 1-Level, 24 mm, Rx Only, Non-Sterile, UDI: (01)00190376268743

    FDA Recall
    Terminated ·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021

    Atec Insignia Anterior Cervical Plate System, REF 136-0478 Insignia, ACP, 4-Level, 78 mm, Rx Only, Non-Sterile, UDI: (01)00190376268705

    FDA Recall
    Terminated ·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021

    Atec Insignia Anterior Cervical Plate System, REF 136-0121, Insignia, ACP, 1-Level, 21 mm, Rx Only, Non-Sterile, UDI: (01)00190376268477

    FDA Recall
    Terminated ·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021

    Atec Insignia Anterior Cervical Plate System, REF 136-0244 Insignia, ACP, 2-Level, 44 mm, Rx Only, Non-Sterile, UDI: (01)00190376268507

    FDA Recall
    Terminated ·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021

    Atec Insignia Anterior Cervical Plate System, REF 136-0117, Insignia, ACP, 1-Level, 17 mm, Rx Only, Non-Sterile, UDI: (01)00190376268439

    FDA Recall
    Terminated ·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021

    Atec Insignia Anterior Cervical Plate System, REF 136-0236 Insignia, ACP, 2-Level, 36 mm, Rx Only, Non-Sterile, UDI: (01)00190376268385

    FDA Recall
    Terminated ·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021