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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 Curved see related information
Date Initiated by Firm November 11, 2019
Create Date December 20, 2019
Recall Status1 Terminated 3 on April 01, 2021
Recall Number Z-0720-2020
Recall Event ID 84295
510(K)Number K090955  
Product Classification Probe, radiofrequency lesion - Product Code GXI
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.
Code Information UDI (01) 05415067028693(17)220131(10) 6865795 lot 6865795
Recalling Firm/
Manufacturer		 Abbott Medical
5050 Nathan Ln N
Plymouth MN 55442-3209
For Additional Information Contact Mr. 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
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.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = GXI and Original Applicant = SMITH & NEPHEW, INC.
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