FlexTrayTM Endopath Cholecsystectomy Tray, Kit Code TNC61.
FDA device recall Z-0754-05 · posted 2005-04-27 · Terminated
Recall details
- Recalling firm
- Ethicon Endo-Surgery
- 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.
- Action taken
- The recalling firm sent letters to hospitals and distributors, dated 12/14/04.
- Root cause
- Other
- Status
- Terminated
- Product code
- MDM
- Quantity affected
- 96 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, Leba
- Date initiated
- 2004-12-15
- Date posted
- 2005-04-27
- Date terminated
- 2012-05-30
- Location
- Cincinnati, OH
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