Signature Laparoscopic Alligator Grasper Instrument Recall Safety Issue
Silex Medical is recalling the Signature Laparoscopic Alligator Grasper with Rotating Shaft (Model 5863050) because insulation on the tube does not fully extend to the proximal end of the shaft, leaving an exposed uninsulated 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: This is an FDA Class II recall of a surgical instrument with a defect involving electrical insulation failure. The exposed conductive area presents a risk of electrical harm during surgical use, which qualifies as a risk-of-harm product defect where injury has not yet been reported.
Plain-English summary
Silex Medical, LLC is recalling the Signature Laparoscopic Instruments, Alligator Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector (Model/REF Number: 5863050). The recall affects 7 units distributed nationwide to Florida, North Dakota, Illinois, California, Texas, Virginia, Michigan, Connecticut, Oregon, Iowa, Mississippi, New Jersey, Idaho, West Virginia, and Hawaii.
The defect involves incomplete insulation on the tube. The insulation does not extend fully to the proximal end of the shaft, creating an exposed (uninsulated) area of the shaft closer to the rotator wheel.
If you have received this device, contact Silex Medical, LLC for instructions on how to proceed. Do not use the affected instruments until guidance has been obtained from the manufacturer.
The recalled product
- Product
- Signature Laparoscopic Instruments, Alligator Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5863050.
- 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 (8)
- 1052
- 1053
- 1054
- 1055
- 1056
- 1057
- 1058
- 1059
Distribution
Distributed nationwide across the United States.
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