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Recall Observatory FDA recall evidence

Device 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.

Z-1956-2015

June 11, 2015

Class II

Product summary

Firm
Justright Surgical, LLC
Event
Event 71521
Status
Terminated
Classification
Class II
Quantity
1452
Official record key
device-enforcement:Z-1956-2015

Official wording

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

Code information: Model Number JR-REL25-2.0 Lot numbers 75ED0114, 75JD1403, 75KD0304, 75KD0726, 75LD1224, 75AE0707, 75AE1406, 75BE1310, 75BE1313, 75CE2605, 75DE0802, and 75DE1524.

Distribution pattern: Distribution - US Nationwide and Ireland.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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