5 results
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45ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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Tribio Implant 7.5mm x 40mm REF M80 SB008 UDI code: (01) 00816125023653(10) EBL10B13C(17) 270630 Tribio" Implant is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, pelvis and posterolateral spine). These osseous defects are surgically created or result from traumatic injury to the bone and are not intrinsic to the stability of the bony structure.
FDA Recall
Open, Classified
·Berkeley Advanced Biomaterials, LLC·Product code MQV·September 2, 2025
StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems
FDA Recall
Open, Classified
·Medtronic Navigation, Inc.·Product code HAW·April 11, 2023
The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients weighing 60 lbs. or greater and having an abdominal thickness greater than 16 cm and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects.
FDA Recall
Open, Classified
·Medtronic Navigation, Inc.-Littleton·Product code OWB·July 25, 2023
Rim Plate, 10-Hole, Left, PRS RX System. Titanium, implantable - Product Usage: The implant temporarily stabilizes bone segments until bony consolidation has taken place. After this, the implant has no more use and can be removed.
FDA Recall
Open, Classified
·I.T.S. GmbH Autal 28 Lasnitzhohe Austria·Product code HRS·May 9, 2019
Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150MM, STERILE PERCUTANEOUS REF: 97733236 The Sterile Percutaneous Reference Pin Set is intended to be used to place and remove a pin percutaneously into bony patient anatomy for rigid attachment of a patient reference during image-guided surgeries using a Medtronic computer-assisted surgery system.
FDA Recall
Open, Classified
·Medtronic Navigation, Inc.·Product code OLO·December 4, 2024