Device product
Justright Surgical, JustRight 5mm Reload, REFJR-REL25-2.0, Sterile, EO, Rx Only It is a replacement cartridge used when more than one firing is required during a surgery.
Z-2691-2014
Product summary
- Event
- Event 69140
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3 cases containing 36 units
- Official record key
device-enforcement:Z-2691-2014
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: 75FD0417
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.