Z-1955-2015 Class II Terminated
FDA device recall Z-1955-2015 was initiated by Justright Surgical, LLC on June 11, 2015 and is designated Class II. 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. The recall status is terminated (terminated August 26, 2015). Affected quantity: 822.
Recall Details
- Product Type
- Devices
- Report Date
- July 8, 2015
- Initiation Date
- June 11, 2015
- Termination Date
- August 26, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 822
Product Description
JustRight 5mm Stapler, JR-ST25-2.0 Stapler is packaged in cases of 6, 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.
Distribution Pattern
Distribution - US Nationwide and Ireland.
Code Information
Model Number JR-ST25-2.0 Lot numbers 75ED0116, 75JD1404, 75KD0308, 75KD1216, 75LD0508, 75AE0709, 75AE2601, 75BE0506, 75BE2315, 75CE1630, 75CE2606, 75DE0102, and 75DE0804 (UK distribution).