Z-1810-2015Class II

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

Name: Z-1810-2015 Navigation System II-Cart, 7700-100-000 with Articulated Arm Camera, 7700-103-001 and Articulated Arm Camera...
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2015-05-04
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2015-05-04 / Terminated / root cause: manufacturing process

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of 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... on 2015-05-04. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1810-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-04
Posted: 2015-06-16
Terminated: 2016-05-16
Recalling firm: Stryker Corp.
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.
Product code: HAW Neurological Stereotaxic Instrument
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Stryker 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 ([email protected]) 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 commerce: 72
Distribution: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1810-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1810-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-24	2015-06-16

Product code HAW

K022365Class IIStryker Navigation System - Hip ModuleStryker Instruments / cleared 2003-01-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)