FDAFDA · Food and drugs·Recall number Z-1756-2014
Stryker 3.0mm 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.
Published June 18, 2014 · Recall initiated: May 22, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Distributor
- Worldwide Distribution - US (nationwide)
- Lot
- Part Number 5820-10-230, Lot Number 13343017
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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