Z-1715-2014 Class II Terminated
FDA device recall Z-1715-2014 was initiated by Stryker Instruments Div. Of Stryker Corporation on May 13, 2014 and is designated Class II. 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 The recall status is terminated (terminated Sep 15, 2014). Affected quantity: 20.
Recall details
- Product Type
- Devices
- Report Date
- Jun 11, 2014
- Initiation Date
- May 13, 2014
- Termination Date
- Sep 15, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20
Product description
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.
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
Distribution pattern
Distributed in the states of AR, CA, IN, LA, MA, MD, MI, MT, NV, and TX.
Code information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1715-2014
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026