# FDA recall Z-0687-2018

> **Cosman Medical, LLC** · Class II · device recall initiated 2017-07-05.

## Product

Nitinol TC Reusable Electrodes (TCN), Model Numbers: 1)TCN-10, 2) TCNK-10-R*, 3)TCN-10-3M, 4) TCNK-15, 5) TCN-15, 6) TCNK-15-C, 7) TCN-15-3M, 8) TCNK-15-R*, 9) TCN-20, 10) TCNK-20, 11) TCN-20-3M*, 12) TCNK-20-C*, 13) TCN-5, 14) TCNK-20-R*, 15) TCN-5-3M, 16) TCNK-5, 17) TCNK-10, 18) TCNK-5-C, 19) TCNK-10-C & 20) TCNK-5-R*.     The TCN devices are indicated for use in radiofrequency (RF) heat lesioning of peripheral nerve tissue only.

## Reason for recall

After multiple reprocessing cycles, the epoxy resin which holds the TCN Electrode in the hub can exhibit signs of damage. In some cases, this damage may result in the inability to fully remove blood and/or tissue residuals prior to cleaning and re-sterilizing the device.

## Distribution

Worldwide Distribution: US (nationwide) and country of Canada.

## Key facts

- **Recall number:** Z-0687-2018
- **Recalling firm:** Cosman Medical, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-07-05
- **Report date:** 2018-02-28
- **Termination date:** 2018-09-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Burlington, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0687-2018

## Citation

> AI Analytics. FDA recall Z-0687-2018. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-0687-2018. Source: US FDA. Licensed CC0.

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