Z-0810-2013 Class II Terminated
FDA device recall Z-0810-2013 was initiated by Mizuho OSI on Dec 17, 2012 and is designated Class II. 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… The recall status is terminated (terminated Apr 15, 2016). Affected quantity: 869 devices.
Recall details
- Product Type
- Devices
- Report Date
- Feb 20, 2013
- Initiation Date
- Dec 17, 2012
- Termination Date
- Apr 15, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 869 devices
Product description
Reason for recall
Distribution pattern
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.
Code information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0810-2013
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026