Medtronic Sofamor Danek USA Inc: Medical Device Recall in 2020 - (Recall #: Z-2692-2020)
See the recall detail below. You can also see other recalls from the same firm in 2020.
Accurian RF Ablation, Cannula pk, Accurian, 100mm, 20G, 10mm, CS Product Number: AC0009 GTIN / UPN: 20763000153599 - 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.
Class II
Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.
Lot # BY19L001 BY19L022 BY19L044 BY19M001 BY19M002 BY20A022 BY20B009
Worldwide distribution - US Nationwide distribution and the countries of Belgium and Australia.
Voluntary: Firm initiated