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Class 2 Device Recall Mizuho Orthopedic Systems, Inc. |
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Date Initiated by Firm |
December 17, 2012 |
Date Posted |
February 13, 2013 |
Recall Status1 |
Terminated 3 on April 15, 2016 |
Recall Number |
Z-0810-2013 |
Recall Event ID |
63991 |
Product Classification |
Table, surgical with orthopedic accessories, ac-powered - Product Code JEA
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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 CA 94587-1234
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For Additional Information Contact |
Keith Lindstrom 510-476-8162 Ext. 128
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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.
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FDA Determined Cause 2 |
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.
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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
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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.
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