FDA-Device2020-01-01Class II
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.
Abbott Medical
Hazard
A manufacturing error caused a single lot of 10mm active tip length Cannulas to be labeled as 5mm active tip length cannulas.
Sold states
Worldwide distribution - US Nationwide and country of Bermuda.
Affected count
470 devices
Manufactured in
5050 Nathan Ln N, Plymouth, MN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0720-2020Don't want to check this manually?
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