Events

Recall of Device Recall JustRight 5mm Stapler

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Justright Surgical, LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    69140
  • Event Risk Class
    Class 2
  • Event Number
    Z-2690-2014
  • Event Initiated Date
    2014-08-27
  • Event Date Posted
    2014-09-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-10-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129735
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Staple, implantable - Product Code GDW
  • 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.
  • 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.

Device

Device Recall JustRight 5mm Stapler
  • Model / Serial
    Lot: 75DD0406
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed in the states of Colorado, California and New York.
  • 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.
  • Manufacturer
    Justright Surgical, LLC

Manufacturer

Justright Surgical, LLC
  • Manufacturer Address
    Justright Surgical, LLC, 6325 Gunpark Dr, Suite G, Boulder CO 80301-3592
  • Manufacturer Parent Company (2017)
    JustRight Surgical LLC
  • Source
    USFDA