Z-0720-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 1, 2020
- Initiation Date
- November 11, 2019
- Termination Date
- April 1, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 470 devices
Product Description
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.
Reason for Recall
A manufacturing error caused a single lot of 10mm active tip length Cannulas to be labeled as 5mm active tip length cannulas.
Distribution Pattern
Worldwide distribution - US Nationwide and country of Bermuda.
Code Information
UDI (01) 05415067028693(17)220131(10) 6865795 lot 6865795