The Recall Desk

FDA (Devices) recall action 69140

Justright Surgical, LLC recalled 2 products on 2014-10-01

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
2014-10-01
Critical
0
Units
—

Why these products were recalled

JustRight Surgical is recalling specific lots of JustRight 5mm Stapler and Reload products because they may deliver poor distal staple formation, past the end of the knife cut.

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

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2014-10-01

    Justright Surgical Recalls 5mm Reloads Due to Poor Staple Formation

    Justright Surgical is recalling specific lots of JustRight 5mm Reloads because they may deliver poor distal staple formation past the end of the knife cut.

    Product
    Justright Surgical, JustRight 5mm Reload, REFJR-REL25-2.0, Sterile, EO, Rx Only It is a replacement cartridge used when more than one firing is required during a surgery.
    Category
    Distribution
    3 states
  • HighFDA (Devices)··2014-10-01

    Justright Surgical Recalls 5mm Staplers Due to Poor Staple Formation

    Justright Surgical is recalling specific lots of JustRight 5mm Staplers because they may deliver poor distal staple formation past the end of the knife cut.

    Product
    Justright Surgical, JustRight 5mm Stapler, REF JR-ST25-2.0, Sterile, EO, Rx Only, JR-ST25-2.0 product is packaged in cases of 6. The JustRight 5mm Stapler is intended for use in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection, and creation of
    Category
    Distribution
    3 states