BEUDAMED
    FDA Recall Terminated

    DT Medical -Hintermann Series H3 Poly Inlay, Size 3 5mm Part Number: 300305 components are prostheses for a mobile bearing ankle joint.

    Recall: Z-0402-2019 · Initiated September 25, 2018

    Recall

    Recall Number
    Z-0402-2019
    Event Number
    81293
    Firm
    DT MedTech, LLC
    FEI Number
    3012104767
    Product Code
    NTG
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    September 25, 2018
    Terminated
    December 5, 2019
    Address
    110 West Rd, Ste 227, Towson, MD, 21204-2341

    Description

    DT Medical -Hintermann Series H3 Poly Inlay, Size 3 5mm Part Number: 300305 components are prostheses for a mobile bearing ankle joint.

    Reason

    Incorrect package labeling identifying the device

    Action

    DT Med Tech LLC initially notified accounts by email notification on 9/25/18 followed by notification letter; The letters explain the process for the identification and return to HealthLink BV (distribution warehouse in The Netherlands) of the products affected (lot AAADP/AAAEM).

    Distribution

    Australia, Ireland, Korea, Germany

    Quantity

    54 units