The Recall Desk

FDA (Devices) recall action 71521

Justright Surgical, LLC recalled 2 products on 2015-07-08

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2015-07-08
Critical
0
Units
2,274

Why these products were recalled

JustRight Surgical is recalling various lots of JustRight 5mm Stapler product because they may deliver incomplete staple formation and incomplete tissue closure.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • HighFDA (Devices)··2015-07-08

    JustRight 5mm Stapler Recalled for Incomplete Staple Formation

    Justright Surgical is recalling JustRight 5mm Staplers because they may deliver incomplete staple formation and incomplete tissue closure.

    Product
    JustRight 5mm Stapler, JR-ST25-2.0 Stapler is packaged in cases of 6, 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 cre
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2015-07-08

    JustRight 5mm Stapler Reloads Recalled for Incomplete Staple Formation

    Justright Surgical is recalling JustRight 5mm Stapler Reloads because they may deliver incomplete staple formation and incomplete tissue closure.

    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 cr
    Category
    Distribution
    0 states