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.
This recall has been terminated (originally issued September 23, 2014).
- Company
- Justright Surgical, Llc
- Recall Initiated
- August 27, 2014
- Posted
- September 23, 2014
- Terminated
- October 6, 2014
- Recall Number
- Z-2691-2014
- Quantity
- 3 cases containing 36 units
- Firm Location
- Boulder, CO
- Official Source
- View on FDA website ↗
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.
Distribution
Distributed in the states of Colorado, California and New York.
Lot / Code Info
Lot: 75FD0417
Root Cause
Process design
Action Taken
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.
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