—#173250

Product

SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT

FDA product code: GDW — Staple, Implantable
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K111825, K160176
Affected lot / code info: N6C0533UX N6C0582UX N6C0657UX N6C0681UX N6E0115UX N6E0116UX N6E0976UX N6E0977UX N6E0978UX N6E0979UX N6F0045UX N6F0046UX N6F0047UX N6F0048UX N6F0049UX N6F0050UX N6F0295UX N6F0503UX N6F0504UX N6F0505UX N6F0506UX N6F0507UX N6F0508UX N6F0509UX N6F0748UX N6F0758UX N6F0759UX N6F0760UX N6F0786UX N6F0787UX N6F0788UX N6G0068UX N6G0270UX N6G0271UX N6G0287UX N6G0288UX N6G0486UX N6G0499UX N6G0784UX N6G0785UX N6G0786UX N6H0105UX N6H0106UX N6H0107UX N6H0155UX N6H0156UX N6H0157UX N6H0173UX N6H0174UX N6H0298UX N6H0299UX N6H0302UX N6H0522UX N6H0693UX N6H0734UX N6H0909UX N6H0946UX N6J0040UX N6J0092UX N6K0302UX N6K0970UX N6K1067UX N6L0152UX N6M0328UX N7A0170UX N7C0475X N7C1091X N7C1092X N7D0104X N8A0087X N8D0035X N8D0225X

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 #173250. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.