FDA-Device2015-07-08Class II
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.
Justright Surgical, LLC
Hazard
JustRight Surgical is recalling various lots of JustRight 5mm Stapler product because they may deliver incomplete staple formation and incomplete tissue closure.
Sold states
Distribution - US Nationwide and Ireland.
Affected count
1452
Manufactured in
6325 Gunpark Dr, Suite G, Boulder, CO, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1956-2015Don't want to check this manually?
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