FDAFDA · Food and drugs·Recall number Z-1715-2014
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.
Published June 11, 2014 · Recall initiated: May 13, 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
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
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Distributor
- Distributed in the states of AR, CA, IN, LA, MA, MD, MI, MT, NV, and TX.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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