Class 2 Device Recall FlexTrayTM Endopath Bariatric Tray

• Date Initiated by Firm: December 15, 2004
• Date Posted: April 27, 2005
• Recall Status: Terminated on May 30, 2012
• Recall Number: Z-0732-05
• Recall Event ID: 30727
• Product Classification: Instrument, Manual, Surgical, General Use - Product Code MDM
• Product: FlexTrayTM Endopath Bariatric Tray, Kit code KBW42
• Code Information: V42E37, V42Y61.
• Recalling Firm/ Manufacturer: Ethicon Endo-Surgery; 4545 Creek Rd; Cincinnati OH 45242-2803
• For Additional Information Contact: Carol Montandon; 513-337-3419
• Manufacturer Reason for Recall: Due to tolerance issues with the device, pins can work free from their respective holes. The result during use could be separation of the handles that could lead to compromised ratchet button functionality. Loss of ratchet button functionality may lead to the end effector being locked in the open or closed position.
• FDA Determined Cause: Other
• Action: The recalling firm sent letters to hospitals and distributors, dated 12/14/04.
• Quantity in Commerce: 12 devices.
• Distribution: The devices were distributed to hospitals and distributors located throughout the United States and to foreign consignees located in Saudi Arabia, Austria, Egypt, United Kingdom, Germany, France, Lebanon, The Netherlands, Spain, Pakistan, South Africa, Italy, United Arab Emirate, Czech Republic, Sweden, Switzerland, Greece, India, Portugal, Slovenia, Hungary, Palestine, and Kuwait.
• 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.