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.
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-2690-2014
- Quantity
- 3 cases containing 18 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: 75DD0406
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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