Z-0073-2012

Mizuho OSI Modular Table System

Name: Z-0073-2012 Mizuho OSI Modular Table System
Creator: Mizuho Orthopedic Systems Inc
Published: 2011-07-29
License: https://open.fda.gov/license/

Mizuho Orthopedic Systems Inc / initiated 2011-07-29 / Terminated

FDA source

Mizuho Orthopedic Systems Inc began a recall of Mizuho OSI Modular Table System; Product Usage: For use in orthopaedic surgery to provide support to a patient on 2011-07-29. The reason FDA records is "Reports of injury related incidents while using the Mizuho OSI Modular Table System". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0073-2012
Status: Terminated
Initiated: 2011-07-29
Posted: 2011-10-27
Terminated: 2013-08-27
Recalling firm: Mizuho Orthopedic Systems Inc
Product: Mizuho OSI Modular Table System; Product Usage: For use in orthopaedic surgery to provide support to a patient.
Product code: JEA Table, Surgical With Orthopedic Accessories, Ac-Powered
Reason for recall: Reports of injury related incidents while using the Mizuho OSI Modular Table System.
FDA root cause: Use error
Action: Mizuho Orthopedic Systems Inc sent a "Field Advisory Notice (Recall)" letters dated July 29, 2011 to all customers using the Modular Table System via Federal Express. The Field Advisory Notice reference the devices involved and explain that there is no need to return any product or to discontinue the use. The letter provides WARNINGS and RECOMMENDATIONS for all users to consider when using the devices and request that the response form be completed as instructed in the advisory communication. The letters also recommend that awareness, training, inspection prior to use, and proper maintenance be established and practiced. The letter recommend that the Field Advisory Notices be posted in prominent areas and communicated to all staff and potential users of this device. Additional support and training can be obtained by contacting Mizuho OSI's Customer Resource Group at 1-800-777-4674. For further questions concerning this notification, contact the Director of Customer Resource Group for assistance (1-800-777-4674, outside the USA 00+1-510-476-8199). Revised letters were approved by CDRH and sent out in January 2012.
Quantity in commerce: 15,011 units
Distribution: Worldwide Distribution - Nationwide USA
Product codes and lots: Model numbers 5803, 5855, 5890, 5891, 5892, 5895, 5927, 5840-726, 5840-831, 5943, 5843A, 5996, 5996I and 6977.; all codes Mizuho OSI, 30031 Ahern Ave., Union City, CA 94587

Product code JEA

K910736Class IJackson Multipurpose Operating TableOrthopedic Systems, Inc. / cleared 1991-05-21

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)