BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1824-2023 · Initiated July 23, 2019

    Recall

    Recall Number
    Z-1824-2023
    Event Number
    92390
    Firm
    New Standard Device Inc
    FEI Number
    3015536247
    Product Code
    KTT
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    July 23, 2019
    Posted
    June 9, 2023
    Address
    4848 Research Dr, San Antonio, TX, 78240-5005

    Description

    '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.

    Action

    On 07/23/2019, the firm emailed a "FIELD SAFETY NOTICE" Letter to customers informing them that threads on posts were stripping out when tensioned during application process. Customers were instructed to: 1. Remove remaining POSTS from their inventory and return to Metalogix Inc. at 4848 Research Drive, San Antonio, TX 78240 Please label return package "ATTENTION: QA Dept" Metalogix Fed-Ex Account# 845 986 983 Metalogix will expedite new product back to customers For further information or questions, contact: Rachel Grimes, Quality Assurance Manager at 833-659-2019, EXT 6 [email protected]

    Distribution

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

    Quantity

    222 units