Z-0720-2020Class II

CLASSIC Radiofrequency Cannula - Curved, 10 cm, SMK Compatible Electrode, REF C-1005-S -

Name: Z-0720-2020 CLASSIC Radiofrequency Cannula - Curved, 10 cm, SMK Compatible Electrode, REF C-1005-S -
Creator: Abbott Medical
Published: 2019-11-11
License: https://open.fda.gov/license/

Abbott Medical / initiated 2019-11-11 / Terminated / root cause: manufacturing process

FDA source

Abbott Medical began a recall of CLASSIC Radiofrequency Cannula - Curved, 10 cm, SMK Compatible Electrode, REF C-1005-S - Product Usage: Disposable Radiofrequency Cannulae are provided in... on 2019-11-11. FDA classified it as Class II and gives the reason as "A manufacturing error caused a single lot of 10mm active tip length Cannulas to be labeled as 5mm active tip length cannulas". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0720-2020
Classification: Class II
Status: Terminated
Initiated: 2019-11-11
Posted: 2019-12-20
Terminated: 2021-04-01
Recalling firm: Abbott Medical
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.
Product code: GXI Probe, 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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm initiated the recall by hand delivered letter on 11/11/2019. The letter explained the issue and requested the return of the recalled product.
Quantity in commerce: 470 devices
Distribution: Worldwide distribution - US Nationwide and country of Bermuda.
Product codes and lots: UDI (01) 05415067028693(17)220131(10) 6865795 lot 6865795

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0720-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0720-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-01	2019-12-20

Product code GXI

K090955Class IISmith & Nephew RF CannulateSmith & Nephew, Inc. / cleared 2009-07-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)