Device recall

Z-1419-2021: Covidien Tri-Staple 2.0 Reinforced Intelligent Reload 60 mm Medium/Thick-For use…

FDA device recall · Class II · Covidien Llc

Key facts

Recall number (Z-number) Z-1419-2021
Recall event 87618
Product Covidien Tri-Staple 2.0 Reinforced Intelligent Reload 60 mm Medium/Thick-For use with Signia stapling system. Staple line reinforcement has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anastomosis. It may be used for…
Product code GDW
Recalling firm Covidien Llc
Recall class Class II
Status Terminated
Termination date May 15, 2024
510(k) numbers K173270
FEI number 1282497

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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