Z-1715-2014Class II

The Stryker NAV3i Platform is a mobile cart platform consisting of the sub-components Stryker Nav3 Graphite...

Name: Z-1715-2014 The Stryker NAV3i Platform is a mobile cart platform consisting of the sub-components Stryker Nav3 Graphite...
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2014-05-13
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2014-05-13 / Terminated

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of 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)... on 2014-05-13. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1715-2014
Classification: Class II
Status: Terminated
Initiated: 2014-05-13
Posted: 2014-06-04
Terminated: 2014-09-15
Recalling firm: Stryker Corp.
Product: 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.
Product code: HAW Neurological Stereotaxic Instrument
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
FDA 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 Whipple M-F 8am-5pm @ 269-389-2921 or [email protected]
Quantity in commerce: 20
Distribution: Distributed in the states of AR, CA, IN, LA, MA, MD, MI, MT, NV, and TX.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1715-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1715-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-11	2014-06-04
Z-1716-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-11	2014-06-04

Product code HAW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)