BEUDAMED
    FDA Recall Open, Classified

    NUVASIVE MAGEC MAGEC 2 Rod. The MAGEC System is used to brace the spine during growth to minimize the progression of scoliosis. REF Model Numbers/NSO Item #/Product Description MC2-4590S / PA0684-001 / MAGEC 2 Rod, 4.5mm 90mm Standard MC2-5590S / PA0684-002 / MAGEC 2 Rod, 5.5,mm 90mm Standard MC2-6090R / PA0684-003 / MAGEC 2 Rod, 6.0mm 70mm Offset MC2-4590R / PA0684-004 / MAGEC 2 Rod, 4.5mm 90mm Offset MC2-5590R / PA0684-005 / MAGEC 2 Rod, 5.5mm 90mm Offset MC2-6090S / PA0684-006 / MAGEC 2 Rod, 6.0mm 70mm Standard MC2-4570S / PA0684-007 / MAGEC 2 Rod, 4.5mm 70mm Standard MC2-5570S / PA0684-008 / MAGEC 2 Rod, 5.5mm 70mm Standard MC2-6070S / PA0684-009 / MAGEC 2 Rod, 6.0mm 70mm Standard MC2-4570R / PA0684-010 / MAGEC 2 Rod, 4.5mm 70mm Offset MC2-5570R / PA0684-011 / MAGEC 2 Rod, 5.5mm 70mm Offset MC2-6070R / PA0864-012 / MAGEC 2 Rod, 6.0mm 70mm Offset MC2-5090S / PA0684-013 / MAGEC 2 Rod, 5.0mm 90mm Standard MC2-5090R / PA0684-014 / MAGEC 2 Rod, 5.0mm 90mm Offset MC2-5070S / PA0684-015 / MAGEC 2 Rod, 5.0mm 70mm Standard MC2-5070R / PA0684-016 / MAGEC 2 Rod, 5.0mm 70mm Offset

    Recall: Z-0559-2023 · Initiated November 1, 2022

    Recall

    Recall Number
    Z-0559-2023
    Event Number
    91125
    Firm
    NuVasive Specialized Orthopedics, Inc.
    FEI Number
    3006179046
    Product Code
    PGN
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    November 1, 2022
    Posted
    December 14, 2022
    Address
    101 Enterprise, Ste 100, Aliso Viejo, CA, 92656-2604

    Description

    NUVASIVE MAGEC MAGEC 2 Rod. The MAGEC System is used to brace the spine during growth to minimize the progression of scoliosis. REF Model Numbers/NSO Item #/Product Description MC2-4590S / PA0684-001 / MAGEC 2 Rod, 4.5mm 90mm Standard MC2-5590S / PA0684-002 / MAGEC 2 Rod, 5.5,mm 90mm Standard MC2-6090R / PA0684-003 / MAGEC 2 Rod, 6.0mm 70mm Offset MC2-4590R / PA0684-004 / MAGEC 2 Rod, 4.5mm 90mm Offset MC2-5590R / PA0684-005 / MAGEC 2 Rod, 5.5mm 90mm Offset MC2-6090S / PA0684-006 / MAGEC 2 Rod, 6.0mm 70mm Standard MC2-4570S / PA0684-007 / MAGEC 2 Rod, 4.5mm 70mm Standard MC2-5570S / PA0684-008 / MAGEC 2 Rod, 5.5mm 70mm Standard MC2-6070S / PA0684-009 / MAGEC 2 Rod, 6.0mm 70mm Standard MC2-4570R / PA0684-010 / MAGEC 2 Rod, 4.5mm 70mm Offset MC2-5570R / PA0684-011 / MAGEC 2 Rod, 5.5mm 70mm Offset MC2-6070R / PA0864-012 / MAGEC 2 Rod, 6.0mm 70mm Offset MC2-5090S / PA0684-013 / MAGEC 2 Rod, 5.0mm 90mm Standard MC2-5090R / PA0684-014 / MAGEC 2 Rod, 5.0mm 90mm Offset MC2-5070S / PA0684-015 / MAGEC 2 Rod, 5.0mm 70mm Standard MC2-5070R / PA0684-016 / MAGEC 2 Rod, 5.0mm 70mm Offset

    Reason

    During accelerated shelf-life extension studies it was noted that the final packaging was experiencing a potential of failure of the sterile packaging barrier which could result in a hazardous situation where the device is no longer sterile.

    Action

    On 11/01/2022, the firm sent an URGENT VOLUNTARY MEDICAL DEVICE RECALL Letter via Docusign/FedEx/email to customers (US/OUS Surgeons and Distributors) informing them that the packaging closure integrity (manufactured with an undersized O-ring of the MAGEC 2 (marketed as MAGEC X) packaged units. As a result of the undersized O-ring gland diameter, the O-ring compression is affected when the hard cap if affixed to the packaging tube. The lack of compression can create a situation where the integrity of the container closure system is compromised potentially impacting the sterile barrier system. Customer are instructed to: 1. Immediately quarantine any affected product. 2. Return all affected products. The NuVasive sales representative will be contacting customers to assist with the return actions. 3. Review this notification to ensure that affected personnel are aware of its contents. 4. For any devices that have been implanted, there are no specific patient monitoring instructions related to this recall that are recommended beyond your existing follow-up schedules. For questions or assistance - contact Sr. Director, Global Quality at 858-344-2667, email [email protected], or the NuVasive Sales Representative.

    Distribution

    Distribution US nationwide including Puerto Rico; Chile, Israel, Jordan, New Zealand, Singapore, Sweden, Thailand, and United Arab Emirates.

    Quantity

    1,873 units