—#173252

Product

SIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMT

FDA product code: GDW — Staple, Implantable
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K111825, K160176
Affected lot / code info: N6E0295UX N6H0576UX N6J1092UX N6K0230UX N6K0938UX N6L0422URX N6L0777UX N6M0607UX N7A0415UX N7C0112X N7D1013X N7E1089X N7F0275X N7F1126X N7G0444X N7H0047X N7H1067X N7J0175X N7L0825X N8A0249X N8A0655X N8B0455X N8B0945X N8C0757X N8C1213X N8D0593X N8D0907X N8E0015X N8G0648X N8J0764X N8K0823KY N8K0840Y N8L0166Y N8L0436Y N8M0845Y N9A0204Y N9B0455Y

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Covidien LLC
Address: 60 Middletown Ave, North Haven, Connecticut 06473-3908

Distribution

Distribution pattern: Nationwide domestic distribution, worldwide foreign distribution.

Timeline

Recall initiated: 2019-05-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #173252. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.