Class 2 Device Recall JustRight 5mm Reload

• Date Initiated by Firm: August 27, 2014
• Date Posted: September 23, 2014
• Recall Status: Terminated on October 06, 2014
• Recall Number: Z-2691-2014
• Recall Event ID: 69140
• 510(K)Number: K132472
• Product Classification: Staple, implantable - Product Code GDW
• Product: Justright Surgical, JustRight 5mm Reload, REFJR-REL25-2.0, Sterile, EO, Rx Only It is a replacement cartridge used when more than one firing is required during a surgery.
• Code Information: Lot: 75FD0417
• Recalling Firm/ Manufacturer: Justright Surgical, LLC; 6325 Gunpark Dr; Suite G; Boulder CO 80301-3592
• For Additional Information Contact: Claire C. Bronstein; 720-287-7146
• Manufacturer 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.
• FDA Determined Cause: Process design
• Action: Consignees were notified via letter on August 27, 2014 in addition, the sales rep will hand deliver the Recall Notification on 8/28/14. Acknowledgement Form will be provided and returned products will be sent to STD Med where it will be held in quarantine.
• Quantity in Commerce: 3 cases containing 36 units
• Distribution: Distributed in the states of Colorado, California and New York.
• 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.

• 510(K) Database: 510(K)s with Product Code = GDW