3 results
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43ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Boston Scientific Vesica Drill-In Bone Locator; sterile, single use only; REF/Catalog no. 820-103, UPN M0068201030.
FDA Recall
Terminated
·Boston Scientific Corp·Product code JDR·June 2, 2006
Stryker 1.3mm Wire Pass Drill Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.
FDA Enforcement
Class II
·Terminated·Stryker Instruments Div. of Stryker Corporation·June 18, 2014
Stryker 1.5mm Wire Pass Drill Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.
FDA Enforcement
Class II
·Terminated·Stryker Instruments Div. of Stryker Corporation·June 18, 2014