Recall Z-0810-2013— Mizuho OSI
Class II · Terminated
Class II FDA medical device recall by Mizuho OSI, initiated 2012-12-17, terminated 2016-04-15. FDA's recall record names no specific 510(k) clearance for this event. Product: Mizuho Orthopedic Table, model 5855, sub assembly 5855-901 Orthopedic Table Spar.. 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..
- Recalling firm
- Mizuho OSI
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-12-17
- Terminated
- 2016-04-15
- Firm location
- Union City, CA, United States
Product description
Mizuho Orthopedic Table, model 5855, sub assembly 5855-901 Orthopedic Table Spar.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.