Z-0091-2021 Class II Terminated
FDA device recall Z-0091-2021 was initiated by Mizuho OSI on Oct 14, 2019 and is designated Class II. 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 The recall status is terminated (terminated Sep 27, 2023). Affected quantity: 174 Arms.
Recall details
- Product Type
- Devices
- Report Date
- Oct 21, 2020
- Initiation Date
- Oct 14, 2019
- Termination Date
- Sep 27, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 174 Arms
Product description
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 pattern
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.
Code information
Model Number: 7887-050 UDI/GTIN 00842230104992 Affected Serial Numbers: 201 through 452 Model 7887-050R UDI/GTIN 00824230108440 Affected Serial Numbers: 234, 235, 248, 255, 341, and 448
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0091-2021
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026