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New Standard Device Inc recalls 'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100
Recalled June 21, 2023 · FDA recall Z-1824-2023 · New Standard Device
Hazard
The threads on posts stripping out when tensioned during application process. · FDA Class II
Units
222 units
Sold at
U.S. Nationwide distribution in the states of AZ, CT, OH, TX, VA.
Description
The threads on posts stripping out when tensioned during application process.
Product
'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805
Manufacturer(s)
New Standard Device Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →