BEUDAMED
    FDA Recall Open, Classified

    Brand Name: CONSTRUX" Mini Ti Spacer System Product Name: CONSTRUX" Mini Ti Spacer System Model/Catalog Number: 37-6005SP 12mm W X 12mm L, 5mm H, 5 Lordotic 37-6005SP 12mm W X 12mm L, 5mm H, 5 Lordotic 37-6005SP 12mm W X 12mm L, 5mm H, 5 Lordotic 37-6006SP 12mm W X 12mm L, 6mm H, 5 Lordotic 37-6006SP 12mm W X 12mm L, 6mm H, 5 Lordotic 37-6006SP 12mm W X 12mm L, 6mm H, 5 Lordotic 37-6007SP 12mm W X 12mm L, 7mm H, 5 Lordotic 37-6007SP 12mm W X 12mm L, 7mm H, 5 Lordotic 37-6007SP 12mm W X 12mm L, 7mm H, 5 Lordotic 37-6008SP 12mm W X 12mm L, 8mm H, 5 Lordotic 37-6008SP 12mm W X 12mm L, 8mm H, 5 Lordotic 37-6008SP 12mm W X 12mm L, 8mm H, 5 Lordotic 37-6009SP 12mm W X 12mm L, 9mm H, 5 Lordotic 37-6009SP 12mm W X 12mm L, 9mm H, 5 Lordotic 37-6009SP 12mm W X 12mm L, 9mm H, 5 Lordotic 37-6010SP 12mm W X 12mm L, 10mm H, 5 Lordotic 37-6010SP 12mm W X 12mm L, 10mm H, 5 Lordotic 37-6010SP 12mm W X 12mm L, 10mm H, 5 Lordotic 37-6011SP 12mm W X 12mm L, 11mm H, 5 Lordotic 37-6011SP 12mm W X 12mm L, 11mm H, 5 Lordotic 37-6011SP 12mm W X 12mm L, 11mm H, 5 Lordotic 37-6012SP 12mm W X 12mm L, 12mm H, 5 Lordotic 37-6012SP 12mm W X 12mm L, 12mm H, 5 Lordotic 37-6012SP 12mm W X 12mm L, 12mm H, 5 Lordotic 37-6105SP 12mm W X 12mm L, 5mm H, Parallel 37-6105SP 12mm W X 12mm L, 5mm H, Parallel 37-6105SP 12mm W X 12mm L, 5mm H, Parallel 37-6106SP 12mm W X 12mm L 6mm H, Parallel 37-6106SP 12mm W X 12mm L 6mm H, Parallel 37-6106SP 12mm W X 12mm L 6mm H, Parallel 37-6107SP 12mm W X 12mm L, 7mm H, Parallel 37-6107SP 12mm W X 12mm L, 7mm H, Parallel 37-6107SP 12mm W X 12mm L, 7mm H, Parallel 37-6108SP 12mm W X 12mm L, 8mm H, Parallel 37-6108SP 12mm W X 12mm L, 8mm H, Parallel 37-6108SP 12mm W X 12mm L, 8mm H, Parallel 37-6109SP 12mm W X 12mm L, 9mm H, Parallel 37-6109SP 12mm W X 12mm L, 9mm H, Parallel 37-6109SP 12mm W X 12mm L, 9mm H, Parallel 37-6110SP 12mm W X 12mm L, 10mm H, Parallel 37-6110SP 12mm W X 12mm L, 10mm H, Parallel 37-6110SP 12mm W X 12mm L, 10mm H, Parallel 37-6111SP 12mm W X 12mm L, 11mm H, Parallel 37-6111SP 12mm W X 12mm L, 11mm H, Parallel 37-6111SP 12mm W X 12mm L, 11mm H, Parallel 37-6112SP 12mm W X 12mm L, 12mm H, Parallel 37-6112SP 12mm W X 12mm L, 12mm H, Parallel 37-6112SP 12mm W X 12mm L, 12mm H, Parallel 37-6206SP 12mm W X 12mm L, 6mm H, 10 Lordotic 37-6206SP 12mm W X 12mm L, 6mm H, 10 Lordotic 37-6206SP 12mm W X 12mm L, 6mm H, 10 Lordotic 37-6207SP 12mm W X 12mm L, 7mm H, 10 Lordotic 37-6207SP 12mm W X 12mm L, 7mm H, 10 Lordotic 37-6207SP 12mm W X 12mm L, 7mm H, 10 Lordotic 37-6208SP 12mm W X 12mm L, 8mm H, 10 Lordotic 37-6208SP 12mm W X 12mm L, 8mm H, 10 Lordotic 37-6208SP 12mm W X 12mm L, 8mm H, 10 Lordotic 37-6209SP 12mm W X 12mm L, 9mm H, 10 Lordotic 37-6209SP 12mm W X 12mm L, 9mm H, 10 Lordotic 37-6209SP 12mm W X 12mm L, 9mm H, 10 Lordotic 37-6210SP 12mm W X 12mm L, 10mm H, 10 Lordotic 37-6210SP 12mm W X 12mm L, 10mm H, 10 Lordotic 37-6210SP 12mm W X 12mm L, 10mm H, 10 Lordotic 37-6211SP 12mm W X 12mm L, 11mm H, 10 Lordotic 37-6211SP 12mm W X 12mm L, 11mm H, 10 Lordotic 37-6211SP 12mm W X 12mm L, 11mm H, 10 Lordotic

    Recall: Z-0896-2026 · Initiated November 3, 2025

    Recall

    Recall Number
    Z-0896-2026
    Event Number
    97862
    Firm
    Orthofix U.S. LLC
    FEI Number
    2183449
    Product Code
    ODP
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    November 3, 2025
    Posted
    December 11, 2025
    Address
    3451 Plano Pkwy, Lewisville, TX, 75056-9453

    Description

    Brand Name: CONSTRUX" Mini Ti Spacer System Product Name: CONSTRUX" Mini Ti Spacer System Model/Catalog Number: 37-6005SP 12mm W X 12mm L, 5mm H, 5 Lordotic 37-6005SP 12mm W X 12mm L, 5mm H, 5 Lordotic 37-6005SP 12mm W X 12mm L, 5mm H, 5 Lordotic 37-6006SP 12mm W X 12mm L, 6mm H, 5 Lordotic 37-6006SP 12mm W X 12mm L, 6mm H, 5 Lordotic 37-6006SP 12mm W X 12mm L, 6mm H, 5 Lordotic 37-6007SP 12mm W X 12mm L, 7mm H, 5 Lordotic 37-6007SP 12mm W X 12mm L, 7mm H, 5 Lordotic 37-6007SP 12mm W X 12mm L, 7mm H, 5 Lordotic 37-6008SP 12mm W X 12mm L, 8mm H, 5 Lordotic 37-6008SP 12mm W X 12mm L, 8mm H, 5 Lordotic 37-6008SP 12mm W X 12mm L, 8mm H, 5 Lordotic 37-6009SP 12mm W X 12mm L, 9mm H, 5 Lordotic 37-6009SP 12mm W X 12mm L, 9mm H, 5 Lordotic 37-6009SP 12mm W X 12mm L, 9mm H, 5 Lordotic 37-6010SP 12mm W X 12mm L, 10mm H, 5 Lordotic 37-6010SP 12mm W X 12mm L, 10mm H, 5 Lordotic 37-6010SP 12mm W X 12mm L, 10mm H, 5 Lordotic 37-6011SP 12mm W X 12mm L, 11mm H, 5 Lordotic 37-6011SP 12mm W X 12mm L, 11mm H, 5 Lordotic 37-6011SP 12mm W X 12mm L, 11mm H, 5 Lordotic 37-6012SP 12mm W X 12mm L, 12mm H, 5 Lordotic 37-6012SP 12mm W X 12mm L, 12mm H, 5 Lordotic 37-6012SP 12mm W X 12mm L, 12mm H, 5 Lordotic 37-6105SP 12mm W X 12mm L, 5mm H, Parallel 37-6105SP 12mm W X 12mm L, 5mm H, Parallel 37-6105SP 12mm W X 12mm L, 5mm H, Parallel 37-6106SP 12mm W X 12mm L 6mm H, Parallel 37-6106SP 12mm W X 12mm L 6mm H, Parallel 37-6106SP 12mm W X 12mm L 6mm H, Parallel 37-6107SP 12mm W X 12mm L, 7mm H, Parallel 37-6107SP 12mm W X 12mm L, 7mm H, Parallel 37-6107SP 12mm W X 12mm L, 7mm H, Parallel 37-6108SP 12mm W X 12mm L, 8mm H, Parallel 37-6108SP 12mm W X 12mm L, 8mm H, Parallel 37-6108SP 12mm W X 12mm L, 8mm H, Parallel 37-6109SP 12mm W X 12mm L, 9mm H, Parallel 37-6109SP 12mm W X 12mm L, 9mm H, Parallel 37-6109SP 12mm W X 12mm L, 9mm H, Parallel 37-6110SP 12mm W X 12mm L, 10mm H, Parallel 37-6110SP 12mm W X 12mm L, 10mm H, Parallel 37-6110SP 12mm W X 12mm L, 10mm H, Parallel 37-6111SP 12mm W X 12mm L, 11mm H, Parallel 37-6111SP 12mm W X 12mm L, 11mm H, Parallel 37-6111SP 12mm W X 12mm L, 11mm H, Parallel 37-6112SP 12mm W X 12mm L, 12mm H, Parallel 37-6112SP 12mm W X 12mm L, 12mm H, Parallel 37-6112SP 12mm W X 12mm L, 12mm H, Parallel 37-6206SP 12mm W X 12mm L, 6mm H, 10 Lordotic 37-6206SP 12mm W X 12mm L, 6mm H, 10 Lordotic 37-6206SP 12mm W X 12mm L, 6mm H, 10 Lordotic 37-6207SP 12mm W X 12mm L, 7mm H, 10 Lordotic 37-6207SP 12mm W X 12mm L, 7mm H, 10 Lordotic 37-6207SP 12mm W X 12mm L, 7mm H, 10 Lordotic 37-6208SP 12mm W X 12mm L, 8mm H, 10 Lordotic 37-6208SP 12mm W X 12mm L, 8mm H, 10 Lordotic 37-6208SP 12mm W X 12mm L, 8mm H, 10 Lordotic 37-6209SP 12mm W X 12mm L, 9mm H, 10 Lordotic 37-6209SP 12mm W X 12mm L, 9mm H, 10 Lordotic 37-6209SP 12mm W X 12mm L, 9mm H, 10 Lordotic 37-6210SP 12mm W X 12mm L, 10mm H, 10 Lordotic 37-6210SP 12mm W X 12mm L, 10mm H, 10 Lordotic 37-6210SP 12mm W X 12mm L, 10mm H, 10 Lordotic 37-6211SP 12mm W X 12mm L, 11mm H, 10 Lordotic 37-6211SP 12mm W X 12mm L, 11mm H, 10 Lordotic 37-6211SP 12mm W X 12mm L, 11mm H, 10 Lordotic

    Reason

    Labeling contains claims that are not consistently present.

    Action

    On November 3, 2025 Orthofix issued a recall notification via Email to affected consignees. In addition to informing consignees about the recall , Orthofix ask consignees to take the following actions: 1. Orthofix is removing claims regarding Nanovate Technology in materials, including but not limited to Operative Techniques, Product Brochures, Medical Education Documents, and the Orthofix website. 2. No product return is being requested. You may continue to use the product. 3. Distribute this Notice to all relevant personnel within your organization. 4. Forward this Notice to other organization or facilities where affected products may have been transferred. 5. Acknowledge this Notice and return the completed receipt form to [email protected]

    Distribution

    Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY and the countries of AU, DE, PR, GB, HU, CZ, CA, CL, AE, ZA, BR.

    Quantity

    40956