Recall Z-2692-2020— Medtronic Sofamor Danek USA Inc
Class II · Terminated
Class II FDA medical device recall by Medtronic Sofamor Danek USA Inc, initiated 2020-06-08, terminated 2022-05-10. It names one FDA 510(k) clearance: K181864. Product: 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.. Reason: Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula..
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-06-08
- Terminated
- 2022-05-10
- Firm location
- Memphis, TN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.
Data sourced from openFDA. This site is unofficial and independent of the FDA.