Coblator II System, 120V. Product Usage: The Coblator II (Model RF8000E) is a bipolar, radiofrequency electrosurgical sy
FDA device recall Z-1323-2015 · posted 2015-03-26 · Terminated
Recall details
- Recalling firm
- ArthroCare Medical Corporation
- Reason for recall
- The recalling firm was notified by the contract manufacturer that they had reversed the L2, L3, L4, or L5 components on the P/N09010 RoHS boards of the Coblator II Controller (Model RF8000E).
- Action taken
- ArthroCare sent an Urgent Medical Device Recall letter dated February 2015 to customers. A response form will be included in the letter and a follow up notifcation letter will be sent to non-responding consignees. The letter identified the affected product, problem and actions to be taken. For questions contact your local Returns Department Representative at 800-343-5717, option 3.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 15 units
- Distribution
- US Nationwide Distribution in the states of TN, IA, AZ, NE, SD, NY, and OK.
- Date initiated
- 2015-02-20
- Date posted
- 2015-03-26
- Date terminated
- 2016-02-26
- Location
- Austin, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARTHROCARE ENT COBLATOR SURGERY SYSTEM (K030108) | Arthrocare Corp. | 2003-02-03 |