Home / Recalls / Justright Surgical, LLC / Z-2690-2014

Z-2690-2014 Class II Terminated

Recalled by Justright Surgical, LLC — Boulder, CO

Recall Details

Product Type
Devices
Report Date
October 1, 2014
Initiation Date
August 27, 2014
Termination Date
October 6, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3 cases containing 18 units

Product Description

Justright Surgical, JustRight 5mm Stapler, REF JR-ST25-2.0, Sterile, EO, Rx Only, JR-ST25-2.0 product is packaged in cases of 6. The JustRight 5mm Stapler is intended for use in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection, and creation of anastomosis.

Reason for Recall

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.

Distribution Pattern

Distributed in the states of Colorado, California and New York.

Code Information

Lot: 75DD0406

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-1955-2015 Class II — JustRight 5mm Stapler, JR-ST25-2.0 Stapler is packaged in cases of 6, placed in (June 11, 2015)
  • Z-2691-2014 Class II — Justright Surgical, JustRight 5mm Reload, REFJR-REL25-2.0, Sterile, EO, Rx Only (August 27, 2014)