Reported Jun 24, 2015 · Terminated

Navigation System II-Cart, 7700-100-000 with Articulated Arm Camera, 7700-103-001 and Articulated Arm Camera,…

Stryker Instruments Div. of Stryker Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Stryker Instruments Div. of Stryker Corporation · 4100 E Milham Ave · Portage, MI · 49002-9704

Is this the product you have?

    • Navigation System II-Cart
    • 7700-100-000 with Articulated Arm Camera
    • 7700-103-001 and Articulated Arm Camera
    • 7700-103-001U
  • Product UsageThe 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
Lot codes and dates
  • 69 of 69 codes

    • Serial numbers 100019
    • 100984
    • 100965
    • 100295
    • 100979
    • 100773
    • 100946
    • 100797
    • 100947
    • 100956
    • 100966
    • 100649
    • 100967
    • 100944
    • 100941
    • 100945
    • 100970
    • 100950
    • 100976
    • 100951
    • 100728
    • 100952
    • 100248
    • 100953
    • 100641
    • 100954
    • 100463
    • 100955
    • 100981
    • 100957
    • 100978
    • 100958
    • 100106
    • 100959
    • 100939
    • 100960
    • 100973
    • 100961
    • 100236
    • 100962
    • 100237
    • 100963
    • 100417
    • 100964. 100940
    • 100968
    • 100975
    • 100969
    • 100977
    • 100972
    • 100105
    • 100974
    • 100214
    • 100980
    • 100492
    • 100982
    • 100493
    • 100983
    • 100948
    • 100986
    • 100704
Amount recalled
72

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 16, 2016 · Data as of Sep 19, 6:48 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.