BEUDAMED
    FDA Recall Open, Classified

    TriMed Wrist Hook Dorsal Impactor, REF IMPCT-WHD; and TriMed Wrist Hook Volar Impactor, REF IMPCT-WHV, both nonsterile, Rx, The firm name on the labels is TriMed Inc., Santa Clarita, CA.

    Recall: Z-0359-2020 · Initiated September 28, 2018

    Recall

    Recall Number
    Z-0359-2020
    Event Number
    83820
    Firm
    TriMed Inc.
    FEI Number
    3001236812
    Product Code
    LXH
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    September 28, 2018
    Address
    27533 Avenue Hopkins, Santa Clarita, CA, 91355-3910

    Description

    TriMed Wrist Hook Dorsal Impactor, REF IMPCT-WHD; and TriMed Wrist Hook Volar Impactor, REF IMPCT-WHV, both nonsterile, Rx, The firm name on the labels is TriMed Inc., Santa Clarita, CA.

    Reason

    The WHD/WHV impactors can rust over time due to an improper manufacturing process.

    Action

    The recalling firm issued letters via email on 9/28/2018 explaining the reason for recall and requesting consignees to identify potentially-affected product and quarantine it until a TriMed representative is able to conduct an inspection.

    Distribution

    Distribution was nationwide. There was military distribution but no government distribution. Foreign distribution was made to Australia, China, South Africa, and Sweden.

    Quantity

    561 devices