Signature Laparoscopic Instruments, Atraumatic Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5864000.
Enforcement
- Recall Number
- Z-1899-2025
- Event ID
- 96755
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Silex Medical, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- June 11, 2025
- Initiation Date
- January 9, 2024
- Classification Date
- June 2, 2025
- Address
- 24 Robert Porter Rd Ste B, N/A, Southington, CT, 06489-1158, United States
Description
Signature Laparoscopic Instruments, Atraumatic Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5864000.
Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.
Model/REF Number: 5864000. UDI-DI: B33158640000. Lot Number: M28187. Serial Numbers: 9565, 9566, 9567, 9568, 9569, 9570, 9571, 9572, 9573, 9574, 9575, 9576, 9577, 9578, 9579, 9580, 9581, 9582, 9583, 9584, 9585, 9586, 9587, 9588, 9589, 9590, 9591, 9592, 9593, 9594, 9595, 9596, 9597, 9598, 9599, 9600, 9601, 9602, 9603, 9604, 9605, 9606, 9607, 9608, 9609, 9610, 9611, 9612, 9613, 9614, 9615, 9616, 9617, 9618, 9619, 9620, 9621, 9622, 9623, 9624, 9625, 9626, 9627, 9628, 9629, 9630, 9631, 9632, 9633, 9634, 9635, 9636, 9637, 9638, 9639, 9640, 9641, 9642, 9643, 9644, 9645, 9646, 9647, 9648, 9649, 9650, 9651, 9652, 9653, 9654, 9655, 9656, 9657, 9658, 9659, 9660, 9661, 9662, 9663, 9664, 9665, 9666, 9667, 9668, 9669, 9670.
US Nationwide distribution in the states of Florida, North Dakota, Illinois, California, Texas, Virginia, Michigan, Connecticut, Oregon, Iowa, Mississippi, New Jersey, Idaho, West Virginia, Hawaii.
105 units