Recall Z-1956-2015— Justright Surgical, LLC
Class II · Terminated
Class II FDA medical device recall by Justright Surgical, LLC, initiated 2015-06-11, terminated 2015-08-26. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: JustRight Surgical is recalling various lots of JustRight 5mm Stapler product because they may deliver incomplete staple formation and incomplete tissue closure..
- Recalling firm
- Justright Surgical, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-06-11
- Terminated
- 2015-08-26
- Firm location
- Boulder, CO, United States
Product description
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.
Reason for recall
JustRight Surgical is recalling various lots of JustRight 5mm Stapler product because they may deliver incomplete staple formation and incomplete tissue closure.
Data sourced from openFDA. This site is unofficial and independent of the FDA.