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Terminated

FlexTrayTM Endopath Bariatric Tray, Kit code KBW22

FDA Recall Z-0731-05 · Posted 2005-04-27

Recalling FirmEthicon Endo-Surgery
Recall StatusTerminated
Product CodeMDM
Date Initiated2004-12-15
Date Terminated2012-05-30
Product Quantity90 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.

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