Device 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 anastomosis.
Z-2690-2014
Product summary
- Event
- Event 69140
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3 cases containing 18 units
- Official record key
device-enforcement:Z-2690-2014
Official wording
Reason: 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.
Code information: Lot: 75DD0406
Distribution pattern: Distributed in the states of Colorado, California and New York.
Derived failure modes
-
Unknown
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.