Signature Laparoscopic Atraumatic Grasper Insulation Defect Recall
Silex Medical is recalling Signature Laparoscopic Instruments (Model 5881033) because insulation on the shaft does not fully extend to the proximal end, leaving an exposed area near the rotator wheel.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA classified this as a Class II recall. The defect (incomplete insulation on an electrosurgical instrument) creates a risk of patient harm during laparoscopic surgery, and no reported illnesses or injuries are stated in the source text, which places it in the High category per the rubric.
Plain-English summary
Silex Medical, LLC is recalling Signature Laparoscopic Instruments, 20mm Atraumatic Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector (Model/REF Number 5881033). The insulation on the tube does not extend fully to the proximal end of the shaft, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.
Two units (Serial Numbers 0107 and 0108, Lot Number M28188) have been distributed nationwide to healthcare facilities in Florida, North Dakota, Illinois, California, Texas, Virginia, Michigan, Connecticut, Oregon, Iowa, Mississippi, New Jersey, Idaho, West Virginia, and Hawaii.
Healthcare providers and patients who have received this device should stop using it immediately and contact Silex Medical, LLC for instructions on return or replacement. The exposed insulation area may pose a safety risk during surgical use.
The recalled product
- Product
- Signature Laparoscopic Instruments, 20mm Atraumatic Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5881033.
- Manufacturer
- Silex Medical, LLC
- Hazard
- electrical-hazard
- insulation-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 0108.
Distribution
Distributed nationwide across the United States.
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