Signature Laparoscopic Instruments, Allis Clamp Grasper with Rotating Shaft and Monopolar Electro...
FDA Recall #Z-1894-2025 — Class II — January 9, 2024
Product Description
Signature Laparoscopic Instruments, Allis Clamp Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5862030.
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.
Recalling Firm
Silex Medical, LLC — Southington, CT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
10 units
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.
Code Information
Model/REF Number: 5862030. UDI-DI: B33158620300. Lot Number: M28182. Serial Numbers: 0709, 0710, 0711, 0712, 0713, 0714, 0715, 0716, 0717, 0718, 0719, 0720
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated