BEUDAMED
    FDA Recall Terminated

    Comfort T-Handle Hudson Connector with Impactor Cap; Part #1006-1; handle is component of the following consignment surgical kits: Harmony 2700-0001-PL, Harmony 2700-0009-PL, Harmony 2900-0001-PL, Harmony 2900-0002-PL, Cadence 1500-0002-PL and Cadence 1500-0008-PL; Distributed by Abbott Spine, Austin, TX 78727.

    Recall: Z-0880-2008 · Initiated December 19, 2007

    Recall

    Recall Number
    Z-0880-2008
    Event Number
    46304
    Firm
    Abbott Spine
    FEI Number
    3000718496
    Product Code
    GZT
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 19, 2007
    Posted
    February 13, 2008
    Terminated
    October 4, 2010
    Address
    12708 Riata Vista Cir, # B-100, Austin, TX, 78727-7167

    Description

    Comfort T-Handle Hudson Connector with Impactor Cap; Part #1006-1; handle is component of the following consignment surgical kits: Harmony 2700-0001-PL, Harmony 2700-0009-PL, Harmony 2900-0001-PL, Harmony 2900-0002-PL, Cadence 1500-0002-PL and Cadence 1500-0008-PL; Distributed by Abbott Spine, Austin, TX 78727.

    Reason

    Dislodged Collar Spring; The collar spring binding on the shaft of generic handle used with multiple surgical instruments has the potential to release the device's internal bearings during use.

    Action

    All medical suppliers with consigned inventory from affected lots were contacted via phone beginning 12/19/07. Consignees notified of potential issue and were asked to inspect their inventory and contact Abbott Spine for return and replacement of the affected handles.

    Distribution

    Worldwide:Medical suppliers in the following states: AR, AZ, CA, CT, FL, IL, LA, MD, MI, MO, MN, NC, NJ, NM, NV, OH, OK, OR, PA, TX, VA and WI. and country of Spain.

    Quantity

    230 handles.