551 results
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Various trauma and sports medicine instruments and implants. Spinal interlaminal fixation orthosis.
FDA Recall
Terminated
·Biomet, Inc.·Product code KWP·April 1, 2016
Malibu Polyaxial Screw, 7.5 x 70mm Part Number 12-7570 Malibu Spinal System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System is to provide immobilization in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.
FDA Recall
Terminated
·SeaSpine, Inc·Product code KWP·March 4, 2009
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
Recirculator 8.0s Disposable Lavage Kit (product code number 8100) , GTIN: 08719992086016. Hyperthermic Perfusion System intended to raise the temperature of the thoracic or peritoneal cavity to a target temperature.
FDA Recall
Terminated
·Eight Medical International BV Laan Van Hildernisse-Noord 2a Bergen Op Zoom Netherlands·Product code LGZ·June 4, 2021