Home / Recalls / Stryker Instruments Div. Of Stryker Corporation / Z-1810-2015

Z-1810-2015 Class II Terminated

Recalled by Stryker Instruments Div. Of Stryker Corporation — Portage, MI

FDA device recall Z-1810-2015 was initiated by Stryker Instruments Div. Of Stryker Corporation on May 4, 2015 and is designated Class II. 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… The recall status is terminated (terminated May 16, 2016). Affected quantity: 72.

Recall details

Product Type: Devices
Report Date: Jun 24, 2015
Initiation Date: May 4, 2015
Termination Date: May 16, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 72

Product description

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.

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.

Distribution pattern

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.

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.

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-1810-2015
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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