Food, drugs, devices › Stryker Instruments Div. of Stryker Corporation
Device recall: The Stryker NAV3i Platform is a mobile cart platform consisting of the sub-components Stryker Nav3 Graphite Camera, SPC-
Stryker Instruments Div. of Stryker Corporation (Portage, MI) initiated this device recall on 13 May 2014; FDA lists 2 product records under event 68261, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 15 Sep 2014. Initiation: voluntary: firm initiated. Stryker Instruments Div. of Stryker Corporation has 55 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Stryker Instruments Div. of Stryker Corporation, Portage, MI.
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
"Distributed in the states of AR, CA, IN, LA, MA, MD, MI, MT, NV, and TX."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1715-2014 | 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,… | 20 | Class II | Terminated | 11 Jun 2014 |
| Z-1716-2014 | 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). | 20 | Class II | Terminated | 11 Jun 2014 |
Context
Other enforcement events for Stryker Instruments Div. of Stryker Corporation
All 55 events for Stryker Instruments Div. of Stryker Corporation
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall 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"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Distributed in the states of AR, CA, IN, LA, MA, MD, MI, MT, NV, and TX."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 15 Sep 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.