Navigation System II-Cart, 7700-100-000 with Articulated Arm Camera, 7700-103-001 and Articulated Arm Camera, 7700-103-0
FDA device recall Z-1810-2015 · posted 2015-06-16 · Terminated
Recall details
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- 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.
- Action taken
- 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 (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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- HAW
- Quantity affected
- 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.
- Date initiated
- 2015-05-04
- Date posted
- 2015-06-16
- Date terminated
- 2016-05-16
- Location
- Portage, MI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STRYKER NAVIGATION SYSTEM - HIP MODULE (K022365) | Stryker Instruments | 2003-01-22 |