Recall Z-0810-2013 ยท JEA Table, Surgical With Orthopedic Accessories, Ac-Powered
Mizuho OSI
Mizuho Orthopedic Table, model 5855, sub assembly 5855-901 Orthopedic Table Spar.
| Date | Feb 13, 2013 (initiated Dec 17, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 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, Can |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.