Z-0091-2021Class II

Levo Arm Label: LEVO ARM REF 7887-050 MIZUHO OSI Refurbished Levo Arm Label: LEVO ARM REF 7887-050R MIZUHO...

Name: Z-0091-2021 Levo Arm Label: LEVO ARM REF 7887-050 MIZUHO OSI Refurbished Levo Arm Label: LEVO ARM REF 7887-050R MIZUHO...
Creator: Mizuho OSI
Published: 2019-10-14
License: https://open.fda.gov/license/

Mizuho Orthopedic Systems Inc / initiated 2019-10-14 / Terminated / root cause: design

FDA source

Mizuho OSI began a recall of 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... on 2019-10-14. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0091-2021
Classification: Class II
Status: Terminated
Initiated: 2019-10-14
Posted: 2020-10-09
Terminated: 2023-09-27
Recalling firm: Mizuho Orthopedic Systems Inc
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.
Product code: JEA Table, Surgical With Orthopedic Accessories, Ac-Powered
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
Root cause tag: design
FDA root cause: Device Design
Action: On 10/14/2019, the firm sent an "URGENT: Medical Device Recall" notification to customers via courier (e.g., UPS or FedEx) and an email to distributors informing them that they have become aware of the potential for fluid ingress rendering the internal electronics inoperable and leading to a failure of the Arm's locking mechanism. The Recalling Firm is instructing customers that they can continue to use the Arm until a replacement Arm is provided, but if either of the following scenarios apply to the devices, to please cease uses immediately and contact the Recalling Firm's Service Department. The two scenarios are: -The customer believes the Arm has been exposed to excessive fluids at any point while in use; -The customer notices any slipping of the Arm while properly installed for its intended use. Customers are asked to refer to the Owner's Manual for specific instructions on how to properly clean all modules of the Head Positioning System, including the Arm. Instructions are found in Section 13 of the manual. In addition, the cleaning instructions are included within the Customer Notification Letter. The Recalling Firm is proactively replacing Arms. Customer should follow the instruction regarding the Exchange Program: -Recalling Firm will provide a replacement Arm at no charge. The timing of the replacement will be based upon product availability and is expected to be completed within 16 weeks. -The Recalling Firm's Sales or Service members will assist customers with the packaging and return of the existing Arm(s) upon the receipt of the upgraded model. Customers are also asked to respond to the Customer Notification Letter by: 1. Confirm receipt and understanding of the notice by signing and returning the response portion of the Notification letter to the Recalling Firm's Regulatory Department at: FAX Number +1-510-429-9945 or email [email protected] 2. Any questions about the exchange plan, call the Recalling Firm's Service Department a
Quantity in commerce: 174 Arms
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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0091-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0091-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-21	2020-10-09

Product code JEA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)