FDA-Device2014-06-18Class II
Stryker 3.5mm Zyphr Elite Round Fluted Bur 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 C
Stryker Instruments Div. of Stryker Corporation
Hazard
There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.
Sold states
Worldwide Distribution - US (nationwide)
Affected count
39
Manufactured in
4100 E Milham Ave, N/A, Portage, MI, United States
Products
Stryker 3.5mm Zyphr Elite Round Fluted Bur 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1762-2014Don't want to check this manually?
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