BEUDAMED
    FDA Recall Terminated

    Harmony MIS Life Instruments, Lumbar Spacer Systems manufactured by Spinal Concepts, Austin, Texas. Part numbers 2851-1-01, 2851-1-30, 2851-2-01, 2851-2-30, 2851-3-01, 2851-3-30, 2851-4-01, 2851-4-30, 2851-4-31, 2851-5-01, 2851-5-30, 2852-2, 2852-4, 2854-1, 2857-1, 2857-2, 2862-1, 2858-1, 2859-1, and 2861-5

    Recall: Z-1343-04 · Initiated April 1, 2004

    Recall

    Recall Number
    Z-1343-04
    Event Number
    28977
    Firm
    Spinal Concepts, Inc
    FEI Number
    3000718496
    Product Code
    MQP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 1, 2004
    Posted
    August 14, 2004
    Terminated
    October 20, 2004
    Address
    5301 Riata Park Ct, Bldg F, Austin, TX, 78727-3436

    Description

    Harmony MIS Life Instruments, Lumbar Spacer Systems manufactured by Spinal Concepts, Austin, Texas. Part numbers 2851-1-01, 2851-1-30, 2851-2-01, 2851-2-30, 2851-3-01, 2851-3-30, 2851-4-01, 2851-4-30, 2851-4-31, 2851-5-01, 2851-5-30, 2852-2, 2852-4, 2854-1, 2857-1, 2857-2, 2862-1, 2858-1, 2859-1, and 2861-5

    Reason

    Handle becomes loose after repeated use.

    Action

    Telephone calls were made 4/1/04 to consignees requesting inspection and return of the product.

    Distribution

    Product was distributed domestically in the following states: TN, MI, KY, CA, CO, OH, KS, WA, TX, NY, AZ, PA, MA, UT, MO, IN, NV, OR, SD, IL, NJ, WI, OK, FL, GA, VA, NC, MD

    Quantity

    646 units