ABC Bend-A-Beam Handpiece REF 134006 Handcontrol Malleable Handpiece, 6" (15.2 cm) QTY: 1 STERILE CONMED CORPORATION 525
FDA device recall Z-2277-2010 · posted 2010-08-25 · Terminated
Recall details
- Recalling firm
- ConMed Electrosurgery
- Reason for recall
- The internal electrode protrudes in front of the ceramic insulator tip of the handpiece.
- 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: 747 cs (7470 units); Int'l: 948 (9480 units)
- Distribution
- Nationwide and International
- Date initiated
- 2008-12-18
- Date posted
- 2010-08-25
- Date terminated
- 2010-10-22
- Location
- Centennial, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BEND-A-BEAM HAND CONTROL MALLEABLE ABC HANDPIECE (K961505) | Conmedcorp | 1996-07-18 |