Home / Recalls / Justright Surgical, LLC / Z-1955-2015

Z-1955-2015 Class II Terminated

Recalled by Justright Surgical, LLC — Boulder, CO

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).

Other recalls by Justright Surgical, LLC

  • Z-1956-2015 Class II — JustRight 5mm Reload, JR-REL25-2.0 Reload is packaged in cases of 12., placed in (June 11, 2015)
  • Z-2690-2014 Class II — Justright Surgical, JustRight 5mm Stapler, REF JR-ST25-2.0, Sterile, EO, Rx Only (August 27, 2014)
  • Z-2691-2014 Class II — Justright Surgical, JustRight 5mm Reload, REFJR-REL25-2.0, Sterile, EO, Rx Only (August 27, 2014)