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U.S. Department of Health and Human Services

Class 1 Device Recall Modular Table System

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  Class 1 Device Recall Modular Table System see related information
Date Initiated by Firm July 29, 2011
Date Posted October 27, 2011
Recall Status1 Terminated 3 on August 27, 2013
Recall Number Z-0073-2012
Recall Event ID 59536
510(K)Number K910736  
Product Classification Table, surgical with orthopedic accessories, ac-powered - Product Code JEA
Product Mizuho OSI Modular Table System;


Product Usage: For use in orthopaedic surgery to provide support to a patient.
Code Information 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
Recalling Firm/
Manufacturer		 Mizuho Orthopedic Systems Inc
30031 Ahern Ave
Union City CA 94587
For Additional Information Contact Kirke Jayne
510-476-8128
Manufacturer Reason
for Recall		 Reports of injury related incidents while using the Mizuho OSI Modular Table System.
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JEA and Original Applicant = ORTHOPEDIC SYSTEMS, INC.
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