The Recall Desk
SevereFDA (Devices)·Z-1715-2014·Announced 2014-06-11

Stryker NAV3i Platform Power Boxes Recalled for Missing Electrical Insulation

Stryker is recalling 20 NAV3i Platform Power Boxes because they may lack electrical insulation on soldering joints, posing a shock hazard.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving significant injury risks or structural defects are rated as Severe (4).

Plain-English summary

Stryker Instruments Div. of Stryker Corporation is recalling 20 Stryker NAV3i Platform Power Boxes. These units were produced between December 9, 2013, and March 7, 2014. The recall is due to a manufacturing defect where the power boxes may have been assembled without electrical insulation on the soldering joints.

The affected power boxes are components of the Stryker NAV3i Platform, a mobile cart navigation system used for cranial, spine, ENT, orthopedic, and trauma procedures. The specific Stryker Product Number is 7700-800-000. The affected serial numbers are 15097, 15098, 15099, 15102, 15103, 15104, 15105, 15106, 15107, 15109, 15110, 15111, 15112, 15113, 15114, 15115, 15116, 15117, and 15118.

These units were distributed in the states of Arkansas, California, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Montana, Nevada, and Texas. The FDA has classified this as a Class II recall. Users should contact Stryker for instructions on how to address the defect.

The recalled product

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
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 (19)

  • 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

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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