Recall Z-1715-2014 ยท HAW Neurological Stereotaxic Instrument
Stryker Instruments Div. of Stryker Corporation
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.
| Date | Jun 4, 2014 (initiated May 13, 2014) |
| Status | Terminated |
| Reason | 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 | Process change control |
| Action | 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 Whipp |
| Quantity | 20 |
| Distribution | Distributed in the states of AR, CA, IN, LA, MA, MD, MI, MT, NV, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.