Justright Surgical, LLC recalls JustRight 5mm Reload, JR-REL25-2.0 Reload is packaged in cases of 12., placed in a tray and sealed with a Tyvek lid. Pr…

Recall date

June 11, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1956-2015

FDA classification

Class II

Brand / firm

Justright Surgical, LLC

Sold / distributed

Distribution - US Nationwide and Ireland.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.