Recall Z-2690-2014— Justright Surgical, LLC

Name: FDA recall Z-2690-2014
Creator: U.S. Food and Drug Administration
Published: 2014-08-27

Class II · Terminated

Class II FDA medical device recall by Justright Surgical, LLC, initiated 2014-08-27, terminated 2014-10-06. It names one FDA 510(k) clearance: K132472. Product: 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: 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..

Recalling firm: Justright Surgical, LLC
Classification: Class II
Status: Terminated
Initiated: 2014-08-27
Terminated: 2014-10-06
Firm location: Boulder, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K132472 — JUSTRIGHT 5MM STAPLER, JUSTRIGHT 5MM RELOADJustright Surgical, LLC·cleared 2014-02-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.