BEUDAMED
    FDA Recall Open, Classified

    stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A221RT, bone stabilization and fixation

    Recall: Z-1467-2023 · Initiated April 10, 2023

    Recall

    Recall Number
    Z-1467-2023
    Event Number
    92078
    Firm
    Wright Medical Technology, Inc.
    FEI Number
    3010667733
    Product Code
    HRS
    Status
    Open, Classified
    Root Cause
    Employee error
    Initiated
    April 10, 2023
    Posted
    April 26, 2023
    Address
    1023 Cherry Rd, Memphis, TN, 38117-5423

    Description

    stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A221RT, bone stabilization and fixation

    Reason

    Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked on the parts.

    Action

    The firm issued an URGENT: MEDICAL DEVICE RECALL notice to its sales representatives and distributors on 04/10/2023 by email and followed with letters disseminated to the remaining consignees via tracked FedEx mailing on Wednesday, April 12. The notice explained the issue and the risk and requested the following actions be taken: Identify all affected products and isolate/quarantine to prevent accidental use. All parties that further distributed the product were directed to notify anyone to the recipients of the affected products. The firm is seeking return of the products.

    Distribution

    US Nationwide distribution.

    Quantity

    50 units