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U.S. Department of Health and Human Services

Enforcement Report - Week of June 11, 2014

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Product Detail

Product Description The Stryker NAV3i Platform is a mobile cart platform consisting of the sub-components Stryker Nav3 Graphite Camera, SPC-3 Computer and IO-Tablet (touch screen) as well as the monitor, articulated arms and cart housing. This Navigation system is used in combination with surgical software for cranial, spine, ENT, orthopedic and trauma procedures.
Recall Number Z-1715-2014
Classification Class II
Code Info Stryker Product Number: 7700-800-000 Stryker Serial Numbers: 15097, 15098, 15099, 15102, 15103, 15104, 15105, 15106, 15107, 15109, 15110, 15111, 15112, 15113, 15114, 15115, 15116, 15117, 15118
Product Distributed Qty 20
Reason For Recall The Stryker NAV3i Platform Power Boxes produced between December 9, 2013 and March 7, 2014 may have been assembled without electrical insulation of the soldering joints

Event Detail

Event Id 68261
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 2014-05-13
Initial Firm Notification of Consignee or Public
Distribution Pattern Distributed in the states of AR, CA, IN, LA, MA, MD, MI, MT, NV, and TX.