Device product

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

Z-1824-2023

July 23, 2019

Class II

Product summary

Firm: New Standard Device Inc
Event: Event 92390
Status: Ongoing
Classification: Class II
Quantity: 222 units
Official record key: device-enforcement:Z-1824-2023

Official wording

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

Code information: Catalog Numbers / Lot Numbers: 100801 / A29318R 100802 / A29318S 100803 / A29318T 100804 / A29318U 100805 / A29318V UDI Codes: Not provided/None

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

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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