Device product
CLASSIC Radiofrequency Cannula - Curved, 10 cm, SMK Compatible Electrode, REF C-1005-S - Product Usage: Disposable Radiofrequency Cannulae are provided in either straight, curved, or curved blunt geometries with a stylet inserted in the cannula. Cannulae are insulated except for the active tip. The active tip determines the size of the radiofrequency lesion.
Z-0720-2020
Product summary
- Firm
- Abbott Medical
- Event
- Event 84295
- Status
- Terminated
- Classification
- Class II
- Quantity
- 470 devices
- Official record key
device-enforcement:Z-0720-2020
Official wording
Reason: A manufacturing error caused a single lot of 10mm active tip length Cannulas to be labeled as 5mm active tip length cannulas.
Code information: UDI (01) 05415067028693(17)220131(10) 6865795 lot 6865795
Distribution pattern: Worldwide distribution - US Nationwide and country of Bermuda.
Derived failure modes
-
Manufacturing or process control
manufacturing error