Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Endopath EZ45 No Knife Linear Stapler (NK45B).

FDA Recall Z-0458-05 · Posted 2005-02-01

Recalling FirmEthicon Endo-Surgery
Recall StatusTerminated
Product CodeGDW
Date Initiated2004-11-21
Date Terminated2008-10-29
Product Quantity65 devices.

Reason for Recall

The product may cause an incomplete staple line to be formed and, therefore, not provide expected control of the tissue.

Firm Action

The firm sent letters, dated 11/21/04, to all consignees.

Root Cause

Other

Distribution Pattern

The product was distributed to hospitals and distributors throughout the United States and to foreign customers located in Korea, China, Republic of Singapore, Argentina, Italy, New Zealand, Austria, Canada, Australia, Brazil, United Arab Emirate, Thailand, Czech Republic, Sweden, Switzerland, Greece, Russia, India, Portugal, Israel, Poland, Hungary, and Uruguay.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K020779PROXIMATE AND ENDOPATH LINEAR CUTTERS AND STAPLERSEthicon Endo-Surgery, Inc. · 2002-06-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑