New Standard Device Inc: Medical Device Recall in 2023 - (Recall #: Z-1824-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 23, 2019

Date Posted: June 21, 2023

Recall Number: Z-1824-2023

Event ID: 92390

Reason for Recall:

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

Status: Ongoing

Product Quantity: 222 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated