BEUDAMED
    FDA Recall Terminated

    Theken L"POD" Titanium Vertebral Body Replacement System, Vu c"POD" PEEK-Optima Vertebral Body Replacement System, c"POD" Titanium Vertebral Body Replacement System The Theken CPOD / LPOD VBR is indicated for use in the thoracolumbar spine (T1 -L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (e.g., fracture). The Theken CPOD / LPOD VBR is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absences of fusion for a prolonged period. Bone graft material is recommended to be packed into the interior openings of the device prior to implantation.The Theken Vu C POD VBR System is indicated for use in the thoracolumbar spine (T1 -L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (e.g., fracture).

    Recall: Z-2202-2011 · Initiated January 18, 2011

    Recall

    Recall Number
    Z-2202-2011
    Event Number
    58179
    Firm
    Integra LifeSciences Corp.
    FEI Number
    3003418325
    Product Code
    MQP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 18, 2011
    Posted
    May 19, 2011
    Terminated
    October 27, 2011
    Address
    311 Enterprise Dr, Plainsboro, NJ, 08536-3344

    Description

    Theken L"POD" Titanium Vertebral Body Replacement System, Vu c"POD" PEEK-Optima Vertebral Body Replacement System, c"POD" Titanium Vertebral Body Replacement System The Theken CPOD / LPOD VBR is indicated for use in the thoracolumbar spine (T1 -L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (e.g., fracture). The Theken CPOD / LPOD VBR is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absences of fusion for a prolonged period. Bone graft material is recommended to be packed into the interior openings of the device prior to implantation.The Theken Vu C POD VBR System is indicated for use in the thoracolumbar spine (T1 -L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (e.g., fracture).

    Reason

    Certain Theken Spine Vertebral Body Replacement Systems were distributed (i) without certain components (spacers and set screws) that are necessary for their use as vertebral body replacements, and (ii) with a component (insertion tool) that is not relevant to the devices' intended use.

    Action

    The firm, Integra Spine, sent an "URGENT: RECALL NOTIFICATION" letter dated January 18, 2011, to their customers. The letter described the product, problem and actions to be taken. The customers were instructed to review their current inventory and return all remaining kits; complete and return the RECALL ACKNOWLEDGMENT AND RETURN FORM via fax to: 877-558-6227 or email: [email protected], and contact Integra Spine Customer Service at 866-942-8698 regarding availability of suitable replacement products. Integra Spine will be taking immediate action to restore your inventory and ensure minimal impact on availability for surgical procedures. Should you have any additional questions, please feel free to contact me at 609-936-2495 or email at [email protected].

    Distribution

    Nationwide distribution: USA including states of: AL, AZ, CA, FL, ID, IL, MD, MI, NH, NM, NV, OH, OK, OR, PA, TX, UT and WI.

    Quantity

    93 Kits