# FDA recall Z-2692-2020

> **Medtronic Sofamor Danek USA Inc** · Class II · device recall initiated 2020-06-08.

## 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 for recall

Insertion difficulty of the probes. The probe was  catching  on a lip inside the hub of the cannula.

## Distribution

Worldwide distribution - US Nationwide distribution and the countries of Belgium and Australia.

## Key facts

- **Recall number:** Z-2692-2020
- **Recalling firm:** Medtronic Sofamor Danek USA Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-06-08
- **Report date:** 2020-07-29
- **Termination date:** 2022-05-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Memphis, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2692-2020

## Citation

> AI Analytics. FDA recall Z-2692-2020. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2692-2020. Source: US FDA. Licensed CC0.

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