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U.S. Department of Health and Human Services

Class 2 Device Recall CLASSIC Radiofrequency Cannula Curved

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 Class 2 Device Recall CLASSIC Radiofrequency Cannula Curvedsee related information
Date Initiated by FirmNovember 11, 2019
Create DateDecember 20, 2019
Recall Status1 Terminated 3 on April 01, 2021
Recall NumberZ-0720-2020
Recall Event ID 84295
510(K)NumberK090955 
Product Classification Probe, radiofrequency lesion - Product Code GXI
ProductCLASSIC 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.
Code Information UDI (01) 05415067028693(17)220131(10) 6865795 lot 6865795
FEI Number 3005334138
Recalling Firm/
Manufacturer		 Abbott Medical
5050 Nathan Ln N
Plymouth MN 55442-3209
For Additional Information ContactMr. Brent Tippen
512-286-4217
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionThe 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 Commerce470 devices
DistributionWorldwide distribution - US Nationwide and country of Bermuda.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = GXI
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