Home / Recalls / COVIDIEN MEDTRONIC / Z-2507-2018

Z-2507-2018 Class II Ongoing

Recalled by COVIDIEN MEDTRONIC — NORTH HAVEN, CT

Recall Details

Product Type
Devices
Report Date
July 25, 2018
Initiation Date
May 22, 2018
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity

Product Description

Tri-Staple 2.0 Black Intelligent Reload for use with Signia stapling system 60 mm Extra Thick, Item Code SIG60AXT

Reason for Recall

Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.

Distribution Pattern

Nationwide U.S.A. Internationally to: Albania, Algeria, Austria, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Guadeloupe, Hungary, Iceland, Ireland, Israel, Italy, Ivory Coast, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, Luxembourg, Macedonia, Malta, Martinique, Moldova, Morocco, Namibia, Netherlands, New Caledonia, Norway, Pakistan, Poland, Portugal, Reunion, Romania, Russian federation, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, United Arab Emirates & United Kingdom

Code Information

N7L0852X, N7M0130X, N8A0145X, N8A0336X, N7L0931X, N7M0639X, N8A0796X & N8B0993X

Other recalls by COVIDIEN MEDTRONIC

  • Z-2503-2018 Class II — Endo GIA 45 mm Articulating Medium/Thick Reload with Tri-Staple Technology, Item (May 22, 2018)
  • Z-2511-2018 Class II — Endo GIA 45 mm Articulating Vascular/Medium Loading Unit with Tri-Staple Technol (May 22, 2018)
  • Z-2514-2018 Class II — Tri-Staple 2.0 Curved Tip Intelligent Reload for use with Signia stapling system (May 22, 2018)
  • Z-2508-2018 Class II — Tri-Staple 2.0 Intelligent Reload for use with Signia stapling system 30 mm Vas (May 22, 2018)
  • Z-2513-2018 Class II — Tri-Staple 2.0 Intelligent Reload for use with Signia stapling system 30 mm Med (May 22, 2018)
  • Z-2510-2018 Class II — Endo GIA 45 mm Extra Thick Black Articulating Reload with Tri-Staple Technology, (May 22, 2018)
  • Z-2509-2018 Class II — Endo GIA 45mm Gray Articulating Vascular Reload with Tri-Staple Technology, Item (May 22, 2018)
  • Z-2505-2018 Class II — Endo GIA 60 mm Extra Thick Black Articulating Reload with Tri-Staple Technology, (May 22, 2018)
  • Z-2504-2018 Class II — Endo GIA 60 mm Articulating Medium/Thick Reload with Tri-StapleTechnology, Item (May 22, 2018)
  • Z-2512-2018 Class II — Endo GIA 45mm Curved Tip Articulating Vascular/Medium Reload with Tri-Staple Tec (May 22, 2018)