Class 2 Device Recall Stryker Flat Panel Arm

• Date Initiated by Firm: April 07, 2010
• Date Posted: May 14, 2010
• Recall Status: Terminated on March 30, 2011
• Recall Number: Z-1605-2010
• Recall Event ID: 55498
• Product Classification: Anesthetic cabinet, table, or tray - Product Code BRY
• Product: Universal Flat Panel Yoke, a component of the Stryker Flat Panel Arm. The yoke is intended to hold a flat panel monitor.
• Code Information: Catalog number: 0682400028 Lot numbers 1003, 1004, 1005, 1006. Serial numbers from 00001-01529
• Recalling Firm/ Manufacturer: Stryker Communications Corp; 1410 Lakeside Pkwy Ste 100; Flower Mound TX 75028-4026
• For Additional Information Contact: 972-410-7310
• Manufacturer Reason for Recall: Some of the pitch shafts were not properly welded which results in the monitor becoming unlevel.
• FDA Determined Cause: Nonconforming Material/Component
• Action: An Urgent: Medical Device Recall letter dated April 19, 2010 was sent to customers. It was recommended that customers continue use of the product unless the monitor becomes unlevel. The customer was notified that a Stryker Representative would contact their facility to coordinate a service call to inspect the affected units. Questions are directed to the firm via phone at 972-410-7617 or via email at .
• Quantity in Commerce: 1498
• Distribution: Worldwide --US and Canada, Australia, China (Hong Kong), Latin America (Mexico, Chile, Ecuador, Costa Rica) .
• Total Product Life Cycle: TPLC 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.