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U.S. Department of Health and Human Services

Class 2 Device Recall Mizuho Orthopedic Systems, Inc.

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 Class 2 Recall
Mizuho Orthopedic Systems, Inc.
see related information
Date Posted February 13, 2013
Recall Status1 Open
Recall Number Z-0810-2013
Recall Event ID 63991
Product Classification Table, Surgical With Orthopedic Accessories, Ac-Powered - Product Code JEA
Product Mizuho Orthopedic Table, model 5855, sub assembly 5855-901 Orthopedic Table Spar.
Code Information Table model 5855, sub assembly 5855-901 Orthopedic Table Spar, manufactured between 1996 and 2007.
Recalling Firm/
Manufacturer
Mizuho OSI
30031 Ahern Ave
Union City, California 94587-1234
Consumer Instructions No consumer action necessary
For Additional Information Contact Keith Lindstrom
510-476-8162 Ext. 128
Manufacturer Reason
for Recall
Possible instability of Orthopedic Table Top. If the epoxy bond fails, the aluminum plug may migrate out of the carbon fiber tube. If this occurs, the Orthopedic Table Spar may need to be replaced to ensure stability of the Orthopedic Table Top.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Mizuho sent a Recall Notification letter dated December 28, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The Orthopedic Table Spar will be replaced at no cost by Mizuho technicians. Customers were informed the potential failure and were advised inspection of tables prior to use. If tables are experiencing the described failure, contact Mizuho Resource Group at 1-800-777-4674, option 2. .
Quantity in Commerce 869 devices
Distribution USA Distribution -- Worldwide Distribution including the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV and WY., and the countries of Australia, Canada, Egypt, Finland, France, Germany, China, Israel, Italy, Japan, Netherlands, New Zealand, P.R. China, Saudi Arabia, Singapore, Slovenia, South Korea, Spain, Taiwan R.O.C., UAE and UK.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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