Date Initiated by Firm |
August 27, 2014 |
Date Posted |
September 23, 2014 |
Recall Status1 |
Terminated 3 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 2 |
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 and Original Applicant = JUSTRIGHT SURGICAL, LLC
|