BEUDAMED
    FDA Recall Open, Classified

    Integra Universal Flexible Arm part number REF 1362275

    Recall: Z-0906-2022 · Initiated February 28, 2022

    Recall

    Recall Number
    Z-0906-2022
    Event Number
    89830
    Firm
    Integra LifeSciences Corp.
    FEI Number
    3003418325
    Product Code
    FXG
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    February 28, 2022
    Address
    1100 Campus Rd, Princeton, NJ, 08540-6650

    Description

    Integra Universal Flexible Arm part number REF 1362275

    Reason

    Excess force used to tighten the Universal Flexible Arm can cause the internal cable to break at the tip, resulting in an unusable condition.

    Action

    Urgent Voluntary Medical Device Recall Notice dated 02/28/2022 was sent via FexEx. Customers are instructed to remove the affected product from service, return it to Integra and complete and submit the attached acknowledgment form. Contact Customer Service with questions: Phone: 1-800-654-2873, Email: [email protected]

    Distribution

    US Nationwide Distribution: AL, AZ, FL, GA, IL, MA, MD, NY, OH, OR, PA, TX

    Quantity

    54