• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall The Stryker NAV3i Platform

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
 Class 2 Recall
The Stryker NAV3i Platform
see related information
Date Posted June 04, 2014
Recall Status1 Terminated on September 15, 2014
Recall Number Z-1715-2014
Recall Event ID 68261
Product Classification Neurological Stereotaxic Instrument - Product Code HAW
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.
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
Recalling Firm/
Manufacturer
Stryker Instruments Div. of Stryker Corporation
4100 E Milham Ave
Portage, Michigan 49002-9704
Manufacturer 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 Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): 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 kellyjo.whipple@stryker.com.
Quantity in Commerce 20
Distribution Distributed in the states of AR, CA, IN, LA, MA, MD, MI, MT, NV, and TX.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
-
-