—#127234

Product

The NAV3i Platform Power Box supplies the electrical components with power (e.g. Stryker Nav3 Graphite Camera, SPC-3 Computer, IO-Tablet (touch screen) and the monitor).

FDA product code: HAW — Neurological Stereotaxic Instrument
Device class: Class 2
Medical specialty: Neurology
Affected lot / code info: Stryker Product Number: 7700-853-000 Stryker Serial Numbers: 10004

Why it was recalled

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

Root cause (FDA determination)

Process change control

Action the firm took

On May 13, 2014, Stryker Instruments sent URGENT MEDICAL DEVICE RECALL notification to their consignees. Notification included the description of the affected product, reason for the recall, risk to health, and actions to be taken by the Customer/User. Once Stryker receives the response from the customer, a Stryker Representative will contact the customer to set up a time to perform the upgrade to the affected power box. Old Power Boxes will be returned to Stryker and placed in an industrial compactor/recycler for destruction. Questions regarding the recall are directed to Kelly Jo Whipple M-F 8am-5pm @ 269-389-2921 or kellyjo.whipple@stryker.com

Recalling firm

Firm: Stryker Instruments Div. of Stryker Corporation
Address: 4100 E Milham Ave, Portage, Michigan 49002-9704

Distribution

Distribution pattern: Distributed in the states of AR, CA, IN, LA, MA, MD, MI, MT, NV, and TX.

Timeline

Recall initiated: 2014-05-13
Posted by FDA: 2014-06-04
Terminated: 2014-09-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #127234. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.