Z-2691-2014 Class II Terminated
FDA device recall Z-2691-2014 was initiated by Justright Surgical, LLC on August 27, 2014 and is designated Class II. 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. The recall status is terminated (terminated October 6, 2014). Affected quantity: 3 cases containing 36 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 1, 2014
- Initiation Date
- August 27, 2014
- Termination Date
- October 6, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 cases containing 36 units
Product Description
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.
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 Pattern
Distributed in the states of Colorado, California and New York.
Code Information
Lot: 75FD0417