Mizuho OSI: Medical Device Recall in 2020 - (Recall #: Z-0091-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: October 14, 2019

Date Posted: October 21, 2020

Recall Number: Z-0091-2021

Event ID: 86482

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

Status: Terminated

Product Quantity: 174 Arms

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

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.

Voluntary or Mandated:

Voluntary: Firm initiated