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