Z-2276-2010
ABC Bend-A-Beam Handpiece REF 134003 Handcontrol Malleable Handpiece, 3" (7.6 cm) QTY: 1 STERILE CONMED...
ConMed Corporation / initiated 2008-12-18 / Terminated / root cause: manufacturing process
ConMed Electrosurgery began a recall of 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... on . The reason FDA records is "The internal electrode protrudes in front of the ceramic insulator at the tip of the handpiece". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-2276-2010
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- ConMed Corporation
- 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.
- Product code
- GEI Electrosurgical, Cutting & Coagulation & Accessories
- Reason for recall
- The internal electrode protrudes in front of the ceramic insulator at the tip of the handpiece.
- Root cause tag
- manufacturing process
- FDA 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 in commerce
- Domestic: 1286 cs (12860 units); Int'l: 1670 cs (16700 units)
- Distribution
- Nationwide and International
- Product codes and lots
- Lot: 0306021 through 0806021
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