FlexTrayTM Endopath Gen. Laparoscopy Tray, Kit Code TGL62.
FDA Recall Z-0749-05 · Posted 2005-04-27
Recalling FirmEthicon Endo-Surgery
Recall StatusTerminated
Product CodeMDM
Date Initiated2004-12-15
Date Terminated2012-05-30
Product Quantity20 devices.
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.
Firm Action
The recalling firm sent letters to hospitals and distributors, dated 12/14/04.
Root Cause
Other
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.