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Terminated

Endopath ETS-FLEX Endoscopic Articulating Linear Cutter, VASCULAR/THIN 35MM

FDA Recall Z-2174-2017 · Posted None

Recalling FirmEthicon Endo-Surgery Inc
Recall StatusTerminated
Product CodeGDW
Date Initiated2017-03-31
Date Terminated2018-05-03
Product Quantity792 units

Reason for Recall

There is a risk that the pinion gear in the device could fail under extreme use cases.

Firm Action

Consignees were sent notification letters and were asked to complete the Business Reply Form (BRF).

Root Cause

Process control

Distribution Pattern

Worldwide distribution. The previously recalled products were distributed to the following countries: China, Japan, Singapore, and South Korea.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K111111ENDOPATH ETS 35MM ENDOSCOPIC LINEAR CUTTER AND RELOADS, AND ETS-FLEX 35MM ENDOSCOPIC ARTICULATING LINEAR CUTTER AND RELOEthicon Endo-Surgery, LLC · 2011-06-08

Official Source

View FDA Recall →

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

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