Z-2691-2020 Class II Terminated
FDA device recall Z-2691-2020 was initiated by Medtronic Sofamor Danek USA Inc on June 8, 2020 and is designated Class II. Reason for recall: Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula. The recall status is terminated (terminated May 10, 2022). Affected quantity: 481 pk.
Recall Details
- Product Type
- Devices
- Report Date
- July 29, 2020
- Initiation Date
- June 8, 2020
- Termination Date
- May 10, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 481 pk
Product Description
Accurian RF Ablation, Cannula pk, Accurian, 150mm, 18G, 10mm, CS Product Number: AC0007 GTIN / UPN: 20763000153568 - Product Usage: (sterile, single-use) comprises an electrically insulated shaft, an active electrode for RF energy delivery, a hub with a female slip luer fitting, and a stylet with a color-coded cap to indicate gauge size. The ACCURIAN RF Cannula included in the ACCURIAN RF Ablation Platform intended for the creation of radiofrequency lesions in nervous tissue.
Reason for Recall
Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.
Distribution Pattern
Worldwide distribution - US Nationwide distribution and the countries of Belgium and Australia.
Code Information
Lot # BY19K031 BY19L011