BEUDAMED
    FDA Recall Terminated

    Stryker 10 MM AVS TL Trial Spacer; Catalog number: 48389410. Manufactured by: Stryker Spine SAS, Cestas, France; Distributed in the US by: Stryker Spine, 2 Pearl Court, Allendale, NJ 07401. Intended for use in the thoraco-lumbar spine.

    Recall: Z-1960-2010 · Initiated May 13, 2010

    Recall

    Recall Number
    Z-1960-2010
    Event Number
    55710
    Firm
    Stryker Spine
    FEI Number
    3004024955
    Product Code
    MDM
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 13, 2010
    Posted
    July 8, 2010
    Terminated
    September 6, 2012
    Address
    2 Pearl Ct, Allendale, NJ, 07401-1611

    Description

    Stryker 10 MM AVS TL Trial Spacer; Catalog number: 48389410. Manufactured by: Stryker Spine SAS, Cestas, France; Distributed in the US by: Stryker Spine, 2 Pearl Court, Allendale, NJ 07401. Intended for use in the thoraco-lumbar spine.

    Reason

    Stryker Spine has received reports of breakage of the distal end of the AVS TL Spacer Trial during the trialling step of the AVS TL procedure.

    Action

    Urgent Product Recall letters, dated May 13, 2010 were sent via Federal Express to all direct accounts (branches and hospitals) with a separate letter to surgeons. The letter identified the affected product and also described the issue, potential hazards, and risk mitigations. The letter also asked customers to quarantine any affected product and return to Stryker Spine. A Customer Response Form was provided and customers should contact their Stryker Spine Sales Rep for additional information on replacement product. Questions should be directed to Tiffani Rogers on 201-760-8206.

    Distribution

    Nationwide Distribution.

    Quantity

    193 units