Medtronic Sofamor Danek USA Inc: Medical Device Recall in 2020 - (Recall #: Z-2691-2020)
See the recall detail below. You can also see other recalls from the same firm in 2020.
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.
Class II
Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.
Lot # BY19K031 BY19L011
Worldwide distribution - US Nationwide distribution and the countries of Belgium and Australia.
Voluntary: Firm initiated