Recall Z-0746-05 ยท MDM Instrument, Manual, Surgical, General Use
Ethicon Endo-Surgery
FlexTrayTM Endopath Cholecsystectomy Tray, Kit Code TDC86S
| Date | Apr 27, 2005 (initiated Dec 15, 2004) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | The recalling firm sent letters to hospitals and distributors, dated 12/14/04. |
| Quantity | 24 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, Swe |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.