Stryker Instruments Div. of Stryker Corporation recalls Stryker 5.0mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut bone an

Recalled June 18, 2014 · FDA recall Z-1758-2014 · Stryker Instruments Div. of Stryker

Hazard

There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments. · FDA Class II

Units

1537

Sold at

Worldwide Distribution - US (nationwide)

Description

There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.

Product

Stryker 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.

Manufacturer(s)

Stryker Instruments Div. of Stryker Corporation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →