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

Ethicon Endo-Surgery Endopath ETS-Flex Articulating Endoscopic Linear Cutter, 35mm Vascular/Thin, Product #ATW35.

FDA Recall Z-0213-04 · Posted 2003-12-17

Recalling FirmEthicon Endo-Surgery
Recall StatusTerminated
Product CodeKOG
Date Initiated2003-11-25
Date Terminated2012-05-09
Product Quantity49,395

Reason for Recall

A defective articulation band may result in improper staple formation with possible hematosis.

Firm Action

The firm contacted their customers by FedEx on 11/25/2003. The product will be returned and destroyed.

Root Cause

Nonconforming Material/Component

Distribution Pattern

The product was shipped to hospitals and distributors located nationwide and worldwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K020779PROXIMATE AND ENDOPATH LINEAR CUTTERS AND STAPLERSEthicon Endo-Surgery, Inc. · 2002-06-05K961390ENDOPATH ETS LINEAR/ETS-FLEX ARTICULATING LINEAR ENDOSCOPIC CUTTEREthicon Endo-Surgery, Inc. · 1996-06-25

Official Source

View FDA Recall →

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

↑