BEUDAMED
    FDA Recall Terminated

    OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, REF ZBH-PSNCREF311-L.

    Recall: Z-0082-2019 · Initiated July 12, 2018

    Recall

    Recall Number
    Z-0082-2019
    Event Number
    80845
    Firm
    Orthosensor, Inc.
    FEI Number
    3008592715
    Product Code
    ONN
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    July 12, 2018
    Terminated
    June 27, 2019
    Address
    1855 Griffin Rd, Ste A310, Dania, FL, 33004-2401

    Description

    OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, REF ZBH-PSNCREF311-L.

    Reason

    Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.

    Action

    Letters dated 7/12/2018 were either delivered by the sales representatives or issued via email to their consignees on 7/13/2018 explaining the reason for recall and requesting return of the devices, if still available, for replacement. The firm expanded the recall via letter dated 8/29/2018 for delivery by sales representatives or via sales representative email on 8/30/2018.

    Distribution

    Distribution was made CA, FL, IL, IN, MI, NY, and NC. Foreign distribution was made to Australia. There was no government/military distribution.

    Quantity

    41 devices