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U.S. Department of Health and Human Services

Class 2 Device Recall JustRight 5mm Reload

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  Class 2 Device Recall JustRight 5mm Reload see related information
Date Initiated by Firm June 11, 2015
Date Posted July 02, 2015
Recall Status1 Terminated 3 on August 26, 2015
Recall Number Z-1956-2015
Recall Event ID 71521
Product Classification Staple, implantable - Product Code GDW
Product 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.
Code Information Model Number JR-REL25-2.0 Lot numbers 75ED0114, 75JD1403, 75KD0304, 75KD0726, 75LD1224, 75AE0707, 75AE1406, 75BE1310, 75BE1313, 75CE2605, 75DE0802, and 75DE1524.
Recalling Firm/
Manufacturer		 Justright Surgical, LLC
6325 Gunpark Dr
Suite G
Boulder CO 80301-3592
For Additional Information Contact Claire C. Bronstein
720-287-7130
Manufacturer 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.
FDA Determined
Cause 2		 Process design
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 orders@justrightsurgical.com 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.
Quantity in Commerce 1452
Distribution Distribution - US Nationwide and Ireland.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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