BEUDAMED
    FDA Recall Terminated

    Brasseler USA, K-WIRE, Double Trocar Smooth, REF KM172-26-35S

    Recall: Z-0707-2022 · Initiated January 28, 2022

    Recall

    Recall Number
    Z-0707-2022
    Event Number
    89555
    Firm
    Brasseler USA, Medical L.L.C.
    FEI Number
    3004949275
    Product Code
    HTY
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    January 28, 2022
    Terminated
    February 3, 2023
    Address
    1 Brasseler Blvd, Savannah, GA, 31419-9576

    Description

    Brasseler USA, K-WIRE, Double Trocar Smooth, REF KM172-26-35S

    Reason

    One lot of product was distributed in unsealed packaging

    Action

    The firm initiated the recall by telephone on 01/28/2022 and followed with a letter delivered by email. The letter explained the issue and requested the consignee set the affected product aside to be returned to the recalling firm.

    Distribution

    US Nationwide distribution in the states of OH, MI, AZ, FL, CA, TN, TX, SC, PA IL, ID.

    Quantity

    231 units