FDA Medical Device Recalls (openFDA)
Ethicon Endo-Surgery: FlexTrayTM Endopath Appendectomy Tray, Kit code KNB19.
- Recall number
- Z-0740-05
- Recalling firm
- Ethicon Endo-Surgery
- Product
- FlexTrayTM Endopath Appendectomy Tray, Kit code KNB19.
- Status
- Terminated
- Initiated
- 2004-12-15
- Posted
- 2005-04-27
- Terminated
- 2012-05-30
- 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
- 62 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.
- Lot, serial or model codes
- V42X9Y, V42100, V4272Y, V42E6A, V42L52, V42P3T, V42X0R, V42Z5A, V4324J, V4355F.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MDM
- Firm FEI
- 1527736
- Firm city
- Cincinnati
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28