Class 2 Device Recall Doro Adapter

• Date Initiated by Firm: February 14, 2007
• Date Posted: May 04, 2007
• Recall Status: Terminated on December 06, 2007
• Recall Number: Z-0780-2007
• Recall Event ID: 37510
• Product Classification: surgical table patient support - Product Code FWZ
• Product: Doro Products Adapter, Product number 5979-300. The adaptor system is attached to OSI''s Spinal Frame, which is an operating room tabletop that is attached to a table base. The Frame is used to support patients during spinal surgery.
• Code Information: Product Number 5979-300, listing 878.4950.
• FEI Number: 2921578
• Recalling Firm/ Manufacturer: Orthopedic Systems Inc; 30031 Ahern Ave; Union City CA 94587-1234
• Manufacturer Reason for Recall: Material used to manufacture accessory bracket does not meet product specification. The screw is normally composed of ''Torlon'', which is yellow. The part was made of "Tercite", which is blue.
• FDA Determined Cause: Other
• Action: A notification letter was sent to all 8 consignees on 02/16/2007. The firm will send service representatives to review any devices on site and replace with the proper part if needed.
• Quantity in Commerce: 8 units distributed.
• Distribution: The products were distributed to 8 consignees in the United States, to ID, IL, NY, and CA.
• 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.