FDA-Device2023-06-21Class II
'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805
New Standard Device Inc
Hazard
The threads on posts stripping out when tensioned during application process.
Sold states
U.S. Nationwide distribution in the states of AZ, CT, OH, TX, VA.
Affected count
222 units
Manufactured in
4848 Research Dr, N/A, San Antonio, TX, United States
Products
'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1824-2023Don't want to check this manually?
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