Recall Z-2691-2014 ยท GDW Staple, Implantable
Justright Surgical, LLC
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.
| Date | Sep 23, 2014 (initiated Aug 27, 2014) |
| Status | Terminated |
| 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. |
| Root cause | Process design |
| Action | Consignees were notified via letter on August 27, 2014 in addition, the sales rep will hand deliver the Recall Notification on 8/28/14. Acknowledgement Form will be provided and returned products will be sent to STD Med where it will be held in quarantine. |
| Quantity | 3 cases containing 36 units |
| Distribution | Distributed in the states of Colorado, California and New York. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132472 | JUSTRIGHT 5MM STAPLER, JUSTRIGHT 5MM RELOAD Justright Surgical, LLC, Feb 11, 2014 |