# FDA recall Z-0335-2022

> **Osteomed, LLC** · Class II · device recall initiated 2021-10-28.

## Product

OsteoMed OsteoPower Power Console:    -OsteoMed OsteoPower Power Console 2 REF 450-0021-00  -OsteoMed D-Power Control Console 2 REF 450-0021-01  -Power Control Console 2 REF ECOS-450-0021-00    -OsteoMed OsteoPower Power Console 2i REF 450-0005-00  -OsteoMed D-Power Control Console 2i REF 450-0005-01  -Power Control Console 2i REF ECOS-450-0005-00    OsteoMed Footswitches:  -OsteoMed BMF Footswitch REF 450-0390  -D-Bi-Directional Master Footswitch REF 450-0380  -D-Uni-Directional Footswitch II REF 450-0350  -D-Bi-Directional Footswitch II REF 450-0360  -D-Uni-Directional Master Footswitch REF 450-0370

## Reason for recall

Due to consoles not in compliance with the latest electrical safety standards IEC 60601 and as a result shocked a patient.

## Distribution

Worldwide distribution - U.S. Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, FL, GA, Guam, HI, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA and WI. The countries of Argentina, Bolivia, Brazil, Canada, Chile, Colombia, Dominican Republic, Ecuador, Germany, Guatemala, Indonesia, Italy, Japan, Korea, Kuwait, Lithuania, Malaysia, Mexico, Russia, Spain, Thailand, Turkey, United Kingdom, and Venezuela.

## Key facts

- **Recall number:** Z-0335-2022
- **Recalling firm:** Osteomed, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-10-28
- **Report date:** 2021-12-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Addison, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0335-2022

## Citation

> AI Analytics. FDA recall Z-0335-2022. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0335-2022. Source: US FDA. Licensed CC0.

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