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U.S. Department of Health and Human Services

Enforcement Report - Week of June 18, 2014

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Product Detail

Product Description Stryker 3.0mm x 3.8mm Neuro Drill Less 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.
Recall Number Z-1780-2014
Classification Class II
Code Info Part Number 5820-107-430S1, Lot Number 14003017,14005017
Product Distributed Qty 916
Reason For Recall There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.

Event Detail

Event Id 68331
Product Type Devices
Status Ongoing
Recalling Firm Stryker Instruments Div. of Stryker Corporation
City Portage
State MI
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-05-22
Initial Firm Notification of Consignee or Public
Distribution Pattern Worldwide Distribution - US (nationwide)