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U.S. Department of Health and Human Services

Class 2 Device Recall JustRight 5mm Stapler

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 Class 2 Device Recall JustRight 5mm Staplersee related information
Date Initiated by FirmAugust 27, 2014
Date PostedSeptember 23, 2014
Recall Status1 Terminated 3 on October 06, 2014
Recall NumberZ-2690-2014
Recall Event ID 69140
510(K)NumberK132472 
Product Classification Staple, implantable - Product Code GDW
ProductJustright 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.
Code Information Lot: 75DD0406
Recalling Firm/
Manufacturer		 Justright Surgical, LLC
6325 Gunpark Dr
Suite G
Boulder CO 80301-3592
For Additional Information ContactClaire 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
ActionConsignees 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 Commerce3 cases containing 18 units
DistributionDistributed in the states of Colorado, California and New York.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = GDW
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