Signature Laparoscopic Sharp Tooth Grasper Insulation Defect Recall
Silex Medical recalls the Signature Laparoscopic Sharp Tooth Grasper due to incomplete insulation on the shaft near the rotator wheel, which creates an electrical hazard during use.
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 involving a surgical instrument with a defect that poses an electrical hazard during patient treatment. Although no illnesses or injuries are reported in the source text, the risk-of-harm nature of the exposed conductor on an electrosurgical device during laparoscopic procedures justifies a High severity rating under the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Silex Medical, LLC is recalling the Signature Laparoscopic Instruments, Sharp Tooth Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector (Model/REF Number 5863020). The insulation on the tube does not extend fully to the proximal end of the shaft, leaving an exposed (uninsulated) area of the shaft closer to the rotator wheel. This defect creates a potential electrical hazard during surgical use.
The affected product was 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. The recall involves 29 units from Lot Number M28184 with serial numbers 2222 through 2253.
Facilities and clinicians using this instrument should stop using the affected units immediately and contact Silex Medical, LLC for further instructions regarding replacement or return of the affected devices.
The recalled product
- Product
- Signature Laparoscopic Instruments, Sharp Tooth Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5863020.
- 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 (20)
- 2223
- 2224
- 2225
- 2226
- 2227
- 2228
- 2229
- 2230
- 2231
- 2232
- 2233
- 2234
- 2235
- 2236
- 2237
- 2238
- 2239
- 2240
- 2241
- 2242
Distribution
Distributed nationwide across the United States.
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