The NAV3i Platform Power Box supplies the electrical components with power (e.g. Stryker Nav3 Graphite Camera, SPC-3 Com

FDA device recall Z-1716-2014 · posted 2014-06-04 · Terminated

Recall details

Recalling firm

Stryker Instruments Div. of Stryker Corporation

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

Action taken

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

Root cause

Process change control

Status

Terminated

Product code

HAW

Quantity affected

20

Distribution

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

Date initiated

2014-05-13

Date posted

2014-06-04

Date terminated

2014-09-15

Location

Portage, MI