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Terminated

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.

FDA Recall Z-2690-2014 · Posted 2014-09-23

Recalling FirmJustright Surgical, LLC
Recall StatusTerminated
Product CodeGDW
Date Initiated2014-08-27
Date Terminated2014-10-06
Product Quantity3 cases containing 18 units

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.

Firm 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.

Root Cause

Process design

Distribution Pattern

Distributed in the states of Colorado, California and New York.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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