FDA Medical Device Recalls (openFDA)
Mizuho Orthopedic Systems Inc: Mizuho OSI Modular Table System; Product Usage: For use in orthopaedic surgery to provide support to a patient.
- Recall number
- Z-0073-2012
- 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.
- Status
- Terminated
- Initiated
- 2011-07-29
- Posted
- 2011-10-27
- Terminated
- 2013-08-27
- Reason
- Reports of injury related incidents while using the Mizuho OSI Modular Table System.
- 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
- 15,011 units
- Distribution
- Worldwide Distribution - Nationwide USA
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K910736"]
- PMA numbers
- not on file
- Product code
- JEA
- Firm FEI
- 2921578
- Firm city
- Union City
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28