Mizuho OSI Modular Table System; Product Usage: For use in orthopaedic surgery to provide support to a patient.

FDA device recall Z-0073-2012 · posted 2011-10-27 · Terminated

Recall details

Recalling firm

Mizuho Orthopedic Systems Inc

Reason for recall

Reports of injury related incidents while using the Mizuho OSI Modular Table System.

Action taken

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.

Root cause

Use error

Status

Terminated

Product code

JEA

Quantity affected

15,011 units

Distribution

Worldwide Distribution - Nationwide USA

Date initiated

2011-07-29

Date posted

2011-10-27

Date terminated

2013-08-27

Location

Union City, CA

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