ABC PROBE REF 160644 5 mm Handswitching Probe, 44 cm QTY: 1 STERILE CONMED CORPORATION 525 French Rd, Utica, NY 13502...
FDA device recall Z-2281-2010 · posted 2010-08-25 · Terminated
Recall details
- Recalling firm
- ConMed Electrosurgery
- Reason for recall
- The internal electrode can protrude in front of ceramic insulator at the tip of the ABC Handpiece used with Conmed Electrosurgical units.
- Action taken
- An Urgent Device Recall notification was issued 12/18/2008, which explained the problem/risk associated with the device, the discontinuance of use and the return of the device. If you have any questions, please contact 800-552-0138, ext. 5225.
- Root cause
- Process design
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- Dom: 46 cs (460 units); Int'l 23 cs (230 units)
- Distribution
- Nationwide and International
- Date initiated
- 2008-12-18
- Date posted
- 2010-08-25
- Date terminated
- 2010-10-22
- Location
- Centennial, CO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LAPAROSCOPIC 5MM ABC PROBE, MODIFICATION (K925903) | Birtcher Medical Systems, Inc. | 1992-12-30 |