FDA Medical Device Recalls (openFDA)
ConMed Electrosurgery: ABC Bend-A-Beam Handpiece REF 134003 Handcontrol Malleable Handpiece, 3" (7.6 cm) QTY: 1 STERILE CONMED CORPORATION 525 FRENCH RD UTICA, NY 13205 ASSEMBLED IN MEXICO (pouch label) ABC Bend-A-Beam Handpiece REF 134003 Handcontrol Malleable Handpiece, 3" (7.6 cm) QTY: 10 STERILE CONMED CORPORATION 525 FRENCH RD UTICA, NY 13205 ASSEMBLED IN MEXICO (case label) Usage: Electrosurgical handpiece for use as monopolar electrosurgical accessory in conjunction with CONMED electrosurgical units equipped with argon beam coagulation.
- Recall number
- Z-2276-2010
- Recalling firm
- ConMed Electrosurgery
- Product
- ABC Bend-A-Beam Handpiece REF 134003 Handcontrol Malleable Handpiece, 3" (7.6 cm) QTY: 1 STERILE CONMED CORPORATION 525 FRENCH RD UTICA, NY 13205 ASSEMBLED IN MEXICO (pouch label) ABC Bend-A-Beam Handpiece REF 134003 Handcontrol Malleable Handpiece, 3" (7.6 cm) QTY: 10 STERILE CONMED CORPORATION 525 FRENCH RD UTICA, NY 13205 ASSEMBLED IN MEXICO (case label) Usage: Electrosurgical handpiece for use as monopolar electrosurgical accessory in conjunction with CONMED electrosurgical units equipped with argon beam coagulation.
- Status
- Terminated
- Initiated
- 2008-12-18
- Posted
- 2010-08-25
- Terminated
- 2010-10-22
- Reason
- The internal electrode protrudes in front of the ceramic insulator at the tip of the handpiece.
- Root cause
- Process design
- Action
- 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.
- Quantity
- Domestic: 1286 cs (12860 units); Int'l: 1670 cs (16700 units)
- Distribution
- Nationwide and International
- Lot, serial or model codes
- Lot: 0306021 through 0806021
- 510(k) numbers
- ["K961505"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 3004491689
- Firm city
- Centennial
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28