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Terminated

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.

FDA Recall Z-0720-2020 · Posted None

Recalling FirmAbbott Medical
Recall StatusTerminated
Product CodeGXI
Date Initiated2019-11-11
Date Terminated2021-04-01
Product Quantity470 devices

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.

Firm 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.

Root Cause

Process control

Distribution Pattern

Worldwide distribution - US Nationwide and country of Bermuda.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K090955SMITH & NEPHEW RF CANNULATESmith & Nephew, Inc. · 2009-07-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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