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    Medtronic Sofamor Danek, TSRH SiLo 5.5 Spinal System, Sagittal Adjusting Screw Implants, Supplement Sets, REF: 8889245, Pedicle Screw Fixation System, Medtronic Sofamor Danek, Memphis, TN 38131

    FDA Recall
    Terminated ·Medtronic Sofamor Danek USA Inc·Product code KWP·August 24, 2007

    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

    SpeedLink 5.5 Transverse Connector Long 50-65mm, non-sterile, 1302-55L

    FDA Recall
    Terminated ·Zimmer Inc.·Product code KWP·January 1, 2009

    SpeedLink 5.5 Transverse Connector Medium 43-51mm, non-sterile, 1302-55M

    FDA Recall
    Terminated ·Zimmer Inc.·Product code KWP·January 1, 2009

    SpeedLink 6.0 Transverse Connector Long 50-60mm, non-sterile, 1304-60L

    FDA Recall
    Terminated ·Zimmer Inc.·Product code KWP·January 1, 2009

    VERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW. Lot H5517628

    FDA Recall
    Terminated ·Medtronic Sofamor Danek USA Inc·Product code KWP·March 26, 2020

    Medicrea Pass LP Blunt K-wire 01.6mm x 500mm-Nitinol Product reference: A06010140

    FDA Recall
    Open, Classified ·Product code KWP·September 16, 2019

    Medacta International SA, M.U.S.T. Rod, REF 03.50.433, Size 5.5mm, Length 480mm, Type Straight, Mat Co-Cr-Mo The rods act as a connector between the different pedicle screws to create a stable construct for the stabilization and fusion of the lumbar and thoracic spine. Indications for Use: The M.U.S.T. pedicle screw system is intended for posterior non-cervical pedicle fixation (T1-S2/ilium) or anterolateral fixation (T8-L5). The pedicle screws are connected by 5.5mm Titanium alloy or CoCrMo rods to create a stable construct. The construct is secured using a set screw made of CoCrMo.

    FDA Recall
    Terminated ·Medacta Usa Inc·Product code KWP·December 7, 2016

    Brand Name: 3B Medical, Inc. Product Name: Ultrasoft Oxygen Cannula, 12 Foot Model / Catalog Number: O2U2012 Lot Number: 20170403 Product Description: Nasal Cannulas for use with Oxygen Concentrators

    FDA Recall
    Open, Classified ·3B Medical, Inc. 203 Avenue A Nw Ste 300 Winter Haven FL 33881-4540·Product code BZB·November 27, 2024