Recall Z-1824-2023— New Standard Device Inc

Name: FDA recall Z-1824-2023
Creator: U.S. Food and Drug Administration
Published: 2019-07-23

Class II · Ongoing

Class II FDA medical device recall by New Standard Device Inc, initiated 2019-07-23. It names one FDA 510(k) clearance: K181630. Product: 'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805. Reason: The threads on posts stripping out when tensioned during application process..

Recalling firm: New Standard Device Inc
Classification: Class II
Status: Ongoing
Initiated: 2019-07-23
Firm location: San Antonio, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K181630 — Revolution External Plating SystemNew Standard Device Dba Metalogix·cleared 2019-05-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

'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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.