JustRight 5mm Stapler, JR-ST25-2.0 Stapler is packaged in cases of 6, placed in a tray and sealed with a Tyvek lid. Prod

FDA device recall Z-1955-2015 · posted 2015-07-02 · Terminated

Recall details

Recalling firm

Justright Surgical, LLC

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.

Action taken

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.

Root cause

Process design

Status

Terminated

Product code

GDW

Quantity affected

822

Distribution

Distribution - US Nationwide and Ireland.

Date initiated

2015-06-11

Date posted

2015-07-02

Date terminated

2015-08-26

Location

Boulder, CO