Device recall

Z-1956-2015: JustRight 5mm Reload, JR-REL25-2.0 Reload is packaged in cases of 12., placed in…

FDA device recall · Class II · Justright Surgical, LLC

Key facts

Recall number (Z-number) Z-1956-2015
Recall event 71521
Product JustRight 5mm Reload, JR-REL25-2.0 Reload is packaged in cases of 12., placed in a tray and sealed with a Tyvek lid. Product Usage: The JustRight 5mm Stapler is intended for use in abdominal, gynecologic, pediatric, and thoracic surgery for the resection, transection, and creation of anastomosis.
Product code GDW
Recalling firm Justright Surgical, LLC
Recall class Class II
Status Terminated
Termination date Aug 26, 2015
FEI number 3010377594

At a glance

  • None 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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