Home / Recalls / New Standard Device Inc / Z-1824-2023

Z-1824-2023 Class II Ongoing

Recalled by New Standard Device Inc — San Antonio, TX

Recall Details

Product Type
Devices
Report Date
June 21, 2023
Initiation Date
July 23, 2019
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
222 units

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.

Distribution Pattern

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

Code Information

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

Other recalls by New Standard Device Inc

  • Z-1649-2022 Class II — Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation S (December 28, 2020)
  • Z-1236-2022 Class II — 1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plat (June 8, 2020)
  • Z-1280-2022 Class II — Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618A (August 14, 2019)