# FDA recall Z-0091-2021

> **Mizuho OSI** · Class II · device recall initiated 2019-10-14.

## Product

Levo Arm Label: LEVO ARM REF 7887-050 MIZUHO OSI    Refurbished Levo Arm Label: LEVO ARM REF 7887-050R  MIZUHO OSI - Product Usage: used with Mizuho OSI spinal surgery tables to provide patient head support and positioning during spinal surgery.

## Reason for recall

Due to the potential for fluid ingress into the Arm which could affect the device's electrical system and lead to a failure of the locking mechanism

## Distribution

Worldwide distribution - U.S. Nationwide distribution including in   states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, LA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, NV, OH, OK, OR, PA, SC, TN, TX, VA, WI, and WV.    The countries of Australia, Belgium, Canada, Columbia, Germany, Israel, South Korea, New Zealand, Poland, United Kingdom, and South Africa.

## Key facts

- **Recall number:** Z-0091-2021
- **Recalling firm:** Mizuho OSI
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-10-14
- **Report date:** 2020-10-21
- **Termination date:** 2023-09-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Union City, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0091-2021

## Citation

> AI Analytics. FDA recall Z-0091-2021. Retrieved 2026-07-08 from https://api.ai-analytics.org/recall/Z-0091-2021. Source: US FDA. Licensed CC0.

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