Signature Laparoscopic Instruments, Sharp Tooth Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5863020.
This recall is currently active, issued June 2, 2025. It was issued by Silex Medical, Llc.
- Company
- Silex Medical, Llc
- Recall Initiated
- January 9, 2024
- Posted
- June 2, 2025
- Recall Number
- Z-1896-2025
- Quantity
- 29 units
- Firm Location
- Southington, CT
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
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.
Lot / Code Info
Model/REF Number: 5863020. UDI-DI: B33158630200. Lot Number: M28184. Serial Numbers: 2222, 2223, 2224, 2225, 2226, 2227, 2228, 2229, 2230, 2231, 2232, 2233, 2234, 2235, 2236, 2237, 2238, 2239, 2240, 2241, 2242, 2243, 2244, 2245, 2246, 2247, 2248, 2249, 2250, 2251, 2252, 2253
Root Cause
Process control
Action Taken
Silex formally notified customers on 01/09/2024. Instructions to consignees included to inspect all instruments that they received from the affected lots for the defect. If any instruments had the issue, the customers were instructed to send it back to their facility under an RGA.