Signature Laparoscopic Instruments, Alligator Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Conne
FDA device recall Z-1898-2025 · posted 2025-06-02 · Open, Classified
Recall details
- Recalling firm
- Silex Medical, LLC
- 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.
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- GEI
- Quantity affected
- 7 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.
- Date initiated
- 2024-01-09
- Date posted
- 2025-06-02
- Location
- Southington, CT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DAVOL LAPAROSCOPIC INSTRUMENTS (GEN SURG REUSABLE) (K914910) | Davol, Inc. | 1992-01-06 |