BEUDAMED
    FDA Recall Open, Classified

    Total Knee Pack, REF CETJ130, medical convenience kits

    Recall: Z-1973-2023 · Initiated April 17, 2023

    Recall

    Recall Number
    Z-1973-2023
    Event Number
    92240
    Firm
    American Contract Systems, Inc.
    FEI Number
    3003419114
    Product Code
    OJH
    Status
    Open, Classified
    Root Cause
    Labeling design
    Initiated
    April 17, 2023
    Posted
    June 15, 2023
    Address
    2610 Ne Industrial Dr, Ste 220, Kansas City, MO, 64117-2648

    Description

    Total Knee Pack, REF CETJ130, medical convenience kits

    Reason

    Incorrect expiration date on product.

    Action

    Owens & Minor sent an "URGENT Product Field Correction" notice on 04/17/2023 to its sole consignee by email. The notice explained the issue and requested the following actions be taken: Identify and segregate and quarantine the affected kits in inventory. Notify all end users of this action and add labels containing correct expiration to kits. The affected product is to be relabeled using the labeling template provided. Report any quality problems or adverse events associated with the products listed in this notification to [email protected]. If you have any questions, contact Regulatory Affairs Manager, Global Products at 470-280-4277 or email: [email protected].

    Distribution

    US Distribution to the state of: MA

    Quantity

    36 units