Recall Z-0720-2020 ยท GXI Probe, Radiofrequency Lesion
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.
| Date | Nov 11, 2019 |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090955 | SMITH & NEPHEW RF CANNULATE Smith & Nephew, Inc., Jul 16, 2009 |