The Recall Desk
HighFDA (Devices)·Z-1716-2014·Announced 2014-06-11

Stryker NAV3i Platform Power Box Recalled for Missing Electrical Insulation

Stryker is recalling 20 NAV3i Platform Power Boxes that may lack electrical insulation on soldering joints, posing a risk of electric shock.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a potential electrical shock hazard. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Stryker Instruments Div. of Stryker Corporation is recalling 20 units of the NAV3i Platform Power Box. These devices supply power to electrical components such as the Stryker Nav3 Graphite Camera, SPC-3 Computer, IO-Tablet, and monitors.

The recall was initiated because the power boxes, produced between December 9, 2013, and March 7, 2014, may have been assembled without electrical insulation on the soldering joints. This defect could potentially expose users to electrical hazards.

The affected units were distributed in Arkansas, California, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Montana, Nevada, and Texas. The specific Stryker Product Number is 7700-853-000, and the affected serial number is 10004. Users should stop using the device and contact Stryker for instructions on repair or replacement.

The recalled product

Product
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).
Manufacturer
Stryker Instruments Div. of Stryker Corporation
Category
Medical Device — Surgical Navigation System
Hazard
Affected units
20

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Stryker Product Number: 7700-853-000 Stryker Serial Numbers: 10004

Distribution

Distributed in 10 states:

Part of a larger recall action

This product is one of 2 recalled by Stryker Instruments Div. of Stryker Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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