Class 2 Device Recall Stryker

• Date Initiated by Firm: November 06, 2003
• Date Posted: December 10, 2003
• Recall Status: Terminated on July 25, 2005
• Recall Number: Z-0183-04
• Recall Event ID: 27655
• Product Classification: Board, Bed - Product Code FPS
• Product: Stryker Universal Imaging Extension (OEM) Catalog Number: R--934-TRIO-A1
• Code Information: Serial Numbers: 217335, 214331.
• FEI Number: 1221538
• Recalling Firm/ Manufacturer: The OR Group; 531 Main St; Acton MA 01720-3934
• For Additional Information Contact: Nancy Royalty; 877-458-4884 Ext. 280
• Manufacturer Reason for Recall: Imaging table with extension may fail if the table leg is incorrectly positioned and the load exceeds the maximum weight of 400 lb
• FDA Determined Cause: Other
• Action: The OR Group forwarded by 2nd day mail on 11/6/03 the repair kit and instructions to the accounts.
• Quantity in Commerce: 2 units
• Distribution: Nationwide. CA, FL, GA, IA MI, MT, NH, OH, NJ, NY, SC, UT, TX, VA
• 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.