FDA Medical Device Recalls (openFDA)
Abbott Medical: 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.
- Recall number
- Z-0720-2020
- 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.
- Status
- Terminated
- Initiated
- 2019-11-11
- Posted
- not on file
- Terminated
- 2021-04-01
- Reason
- A manufacturing error caused a single lot of 10mm active tip length Cannulas to be labeled as 5mm active tip length cannulas.
- 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
- 470 devices
- Distribution
- Worldwide distribution - US Nationwide and country of Bermuda.
- Lot, serial or model codes
- UDI (01) 05415067028693(17)220131(10) 6865795 lot 6865795
- 510(k) numbers
- ["K090955"]
- PMA numbers
- not on file
- Product code
- GXI
- Firm FEI
- 3005334138
- Firm city
- Plymouth
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28