FDA recall Z-1824-2023

New Standard Device Inc · Class II · device

Product

'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805

Reason for recall

The threads on posts stripping out when tensioned during application process.

Distribution

U.S. Nationwide distribution in the states of AZ, CT, OH, TX, VA.

Key facts

Status
Ongoing
Initiation date
2019-07-23
Report date
2023-06-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
San Antonio, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1824-2023