Device product
Stryker 3.0mm Round Fluted Bur Soft Touch 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.
Z-1754-2014
Product summary
- Event
- Event 68331
- Status
- Terminated
- Classification
- Class II
- Quantity
- 609
- Official record key
device-enforcement:Z-1754-2014
Official wording
Reason: There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.
Code information: Part Number 5820-10-130, Lot Numbers 13346017, 13346027
Distribution pattern: Worldwide Distribution - US (nationwide)
Derived failure modes
-
Unknown
There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.