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U.S. Department of Health and Human Services

Class 2 Device Recall Navigation System IICart with Articulated Arm Camera

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 Class 2 Device Recall Navigation System IICart with Articulated Arm Camerasee related information
Date Initiated by FirmMay 04, 2015
Date PostedJune 16, 2015
Recall Status1 Terminated 3 on May 16, 2016
Recall NumberZ-1810-2015
Recall Event ID 71268
510(K)NumberK022365 
Product Classification Neurological stereotaxic Instrument - Product Code HAW
ProductNavigation 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.
Code Information 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, 100987, 100949, 100988, 100227, 100989, 100971, 100133, 100134, 100942.
Recalling Firm/
Manufacturer
Stryker Instruments Div. of Stryker Corporation
4100 E Milham Ave
Portage MI 49002-9704
For Additional Information ContactKelly Jo Davis
269-389-2921
Manufacturer Reason
for Recall
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 Determined
Cause 2
Process control
ActionStryker sent an Urgent Medical Device Recall Notification letter dated May 18, 2013 to Domestic customers notice via FedEx overnight and Sales Representatives via email. The International Subsidiaries will also be notified via email. Customers are instructed to immediately review the Recall Notification adn complete the following: Immediately check all stock areas and/or operating room storage for affected equipment found. Complete the enclosed Business Reply Form (BRF) to confirm receipt of this notification and identify how many affected items are currently in inventory. Please complete and return the BRF even if they dont have any affected product on hand. If customers have further distributed this product, they are asked to forward this letter and the attached BRF to all affected locations. Please indicate each location and serial number(s) on the BRF. Fax (866-521-2762) or email (kellyjo.davis@stryker.com) the completed BRF to Stryker Instruments Regulatory Department, Attn: Kelly Jo Davis. A Stryker Representative will contact the facility to set up a time to perform the additional inspection of the weld seam on the Navigation System II-Cart, Articulated Arm Camera.
Quantity in Commerce72
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = HAW
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