Open, Classified

EGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT

FDA Recall Z-1828-2019 · Posted None

Recall StatusOpen, Classified

Product CodeGDW

Date Initiated2019-05-17

Product Quantity3,113,280

Reason for Recall

The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis.

Firm Action

All consignees were notified by letter delivered via Federal Express and/or certified mail beginning May 17, 2019. The letter informs customers of the recall of specific item codes and production lots of Covidien Endo GIA Articulating Reloads with Tri-Staple Technology due to the potential for a device to be missing one of two pin components that maintain alignment of the device jaws. Through this notification customers are instructed to take the following actions: " Immediately quarantine and discontinue use of the affected item codes and lots. " Return affected product. " Forward the information to anyone who they have distributed affected Covidien Endo GIA" Articulating Reloads with Tri-Staple Technology. " Complete the Recalled Product Return Form. If you have any questions regarding this communication, please contact your Medtronic representative or Customer Service at 800-962-9888, option 2.

Root Cause

Process control

Distribution Pattern

Nationwide domestic distribution, worldwide foreign distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K160176Signia StaplerCovidien · 2016-04-26 K111825ENDO GIA(TM) STAPLERS, DST SERIES(TM) GIA(TM) STAPLERS, DST SERIES(TM) TA(TM) STAPLERSCovidien, Formerly US Surgical A Divison of Tyco H · 2011-10-25

Official Source

View FDA Recall →

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