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Stryker Instruments Div. of Stryker Corporation recalls Navigation System II-Cart, 7700-100-000 with Articulated Arm Camera, 7700-103-001 and Articulated Arm Camera, 7700-103-0
Recalled June 24, 2015 · FDA recall Z-1810-2015 · Stryker Instruments Div. of Stryker
Hazard
Stryker initiated a device recall of the Navigation System II-Cart, Camera Articulated Arm because there is a potential that the weld seam between the main stud and the two flaps on the Articulated Arm was not welded in the correct location, which may result in a potential failure of the arm joint. · FDA Class II
Units
72
Sold at
Worldwide Distribution - US Nationwide in the states of AR, CO, FL, GA, IN, KS, KY, MA, MI, NC, NE, NJ, NY, OH, OK, PA, TX, WA, WY and the countries of Canada, Europe, and Asia.
Description
Stryker initiated a device recall of the Navigation System II-Cart, Camera Articulated Arm because there is a potential that the weld seam between the main stud and the two flaps on the Articulated Arm was not welded in the correct location, which may result in a potential failure of the arm joint.
Product
Navigation System II-Cart, 7700-100-000 with Articulated Arm Camera, 7700-103-001 and Articulated Arm Camera, 7700-103-001U Product Usage: The Navigation System II-Cart is intended to be used as a platform for computer assisted surgery as part of the Stryker Navigation System. The intended use of the complete Stryker Navigation System is defined by the Stryker application modules.
Manufacturer(s)
Stryker Instruments Div. of Stryker Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →