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.
FDA Recall Z-1956-2015 · Posted 2015-07-02
Recalling FirmJustright Surgical, LLC
Recall StatusTerminated
Product CodeGDW
Date Initiated2015-06-11
Date Terminated2015-08-26
Product Quantity1452
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.
Firm Action
JustRight Surgical sent an Urgent Medical Device Recall letter dated June 12, 2015 to aaffected customers and distributor via an email. The letter identified the affected product, problem and actions to be taken. Custers were instructed Review, complete, and return the enclosed Acknowledgement Form directly to Rep, your Sales Representative or email to [email protected] or fax to (720) 287-7135.
The following assistance is available:
" For questions related to the issue or product replacement, please contact your local sales representative, Rep, or contact JustRight Surgical Customer Service at (866) 683-1743, Monday through Friday from 7:30 AM to 5:00 PM MST.
" For questions related to product pick-up by JustRight Surgical, please also contact your local sales representative or Customer Service (866) 683-1743. Return instructions are provided on the Acknowledgement Form.
" For questions related to the Acknowledgement Form and its return, please contact the JustRight Surgical Director of Quality Systems at (720) 287-7146.
Root Cause
Process design
Distribution Pattern
Distribution - US Nationwide and Ireland.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.