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Stryker Instruments Div. of Stryker Corporation Recall: Stryker 5.0mm Round Fluted Bur Agg

Stryker Instruments Div. of Stryker Corporation Recall: Stryker 5.0mm Round Fluted Bur Agg is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Stryker Instruments Div. of Stryker Corporation; Product: Stryker 5.0mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended

Recalling firmStryker Instruments Div. of Stryker Corporation
ProductStryker 5.0mm Round Fluted Bur Aggressive 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.
Reason for recallThere may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusTerminated
DistributionWorldwide Distribution - US (nationwide)
Recall initiated20140522
Recall numberZ-1758-2014
Categorydevice
StateMI
CountryUnited States

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