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.
FDA Recall Z-2691-2014 · Posted 2014-09-23
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Recalling FirmJustright Surgical, LLC
Recall StatusTerminated
Product CodeGDW
Date Initiated2014-08-27
Date Terminated2014-10-06
Product Quantity3 cases containing 36 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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