BEUDAMED
    FDA Recall Terminated

    Allez Spine Laguna Pedicle Screw System; Catalog Number: IT-FN1003 Del Mar Pedicle Screw System; IT-ST1001Vertebrae Rotation Tool; IT-H W1001Hex Wrench; IT-CB1001Coronal Bender-L; IT-CB1002 Coronal Bender-R; IT-PH1001Power Rod Holder; IT-BP1001 Thoracic Ball Handle Probe, Curved; IT-BP1002 Thoracic Ball Handle Probe, Straight; DM-MR0530 Monoaxial Screw Non-Winged, Size 5 x 30; DM-MR0535 Monoaxial Screw Non-Winged, Size 5 x 35; DM-MR0540 Monoaxial Screw Non-Winged, Size 5 x 40; DM-MR0545 Monoaxial Screw Non-Winged, Size 5 x 45; DM-MW0530 Monoaxial Screw Winged, Size 5 x 30; DM-MW0535 Monoaxial Screw Winged, SizeS x 35; DM-MW0540 Monoaxial Screw Winged, Size S x 40; DM-MW0545 Monoaxial Screw Winged, Size 5 x 45; DM-MR0630 Monoaxial Screw Non-Winged, Size 6 x 30; DM-MR0635 Monoaxial Screw Non-Winged, Size 6 x 35; DM-MR0640 Monoaxial Screw Non-Winged, Size 6 x 40; DM-MR0645 Monoaxial Screw Non-Winged, Size 6 x 45; DM-MR0650 Monoaxial Screw Non-Winged, Size 6 x 50; DM-MW0630 Monoaxial Screw Winged, Size 6 x 30; DM-MW0635 Monoaxial Screw Winged, Size 6 x 35; DM-MW0640 Monoaxial Screw Winged, Size 6 x 40; DM-MW0645 Monoaxial Screw Winged, Size 6 x 45; DM-MR0735 Monoaxial Screw Non-Winged, Size 7 x 35 DM-MR0740 Monoaxial Screw Non-Winged, Size 7 x 40; DM-MR0745 Monoaxial Screw Non-Winged, Size 7 x 45; RD-ST5541 Straight Rod, 4mm Hex Intended to help provide correction, immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral space.

    Recall: Z-0153-2009 · Initiated August 21, 2008

    Recall

    Recall Number
    Z-0153-2009
    Event Number
    49444
    Firm
    Allez Spine, LLC
    FEI Number
    3005032381
    Product Code
    MNI
    Status
    Terminated
    Root Cause
    Pending
    Initiated
    August 21, 2008
    Posted
    October 28, 2008
    Terminated
    January 19, 2010
    Address
    2301 Dupont Dr, Ste 510, Irvine, CA, 92612-7518

    Description

    Allez Spine Laguna Pedicle Screw System; Catalog Number: IT-FN1003 Del Mar Pedicle Screw System; IT-ST1001Vertebrae Rotation Tool; IT-H W1001Hex Wrench; IT-CB1001Coronal Bender-L; IT-CB1002 Coronal Bender-R; IT-PH1001Power Rod Holder; IT-BP1001 Thoracic Ball Handle Probe, Curved; IT-BP1002 Thoracic Ball Handle Probe, Straight; DM-MR0530 Monoaxial Screw Non-Winged, Size 5 x 30; DM-MR0535 Monoaxial Screw Non-Winged, Size 5 x 35; DM-MR0540 Monoaxial Screw Non-Winged, Size 5 x 40; DM-MR0545 Monoaxial Screw Non-Winged, Size 5 x 45; DM-MW0530 Monoaxial Screw Winged, Size 5 x 30; DM-MW0535 Monoaxial Screw Winged, SizeS x 35; DM-MW0540 Monoaxial Screw Winged, Size S x 40; DM-MW0545 Monoaxial Screw Winged, Size 5 x 45; DM-MR0630 Monoaxial Screw Non-Winged, Size 6 x 30; DM-MR0635 Monoaxial Screw Non-Winged, Size 6 x 35; DM-MR0640 Monoaxial Screw Non-Winged, Size 6 x 40; DM-MR0645 Monoaxial Screw Non-Winged, Size 6 x 45; DM-MR0650 Monoaxial Screw Non-Winged, Size 6 x 50; DM-MW0630 Monoaxial Screw Winged, Size 6 x 30; DM-MW0635 Monoaxial Screw Winged, Size 6 x 35; DM-MW0640 Monoaxial Screw Winged, Size 6 x 40; DM-MW0645 Monoaxial Screw Winged, Size 6 x 45; DM-MR0735 Monoaxial Screw Non-Winged, Size 7 x 35 DM-MR0740 Monoaxial Screw Non-Winged, Size 7 x 40; DM-MR0745 Monoaxial Screw Non-Winged, Size 7 x 45; RD-ST5541 Straight Rod, 4mm Hex Intended to help provide correction, immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral space.

    Reason

    This action is being taken voluntarily as a result of a Warning Letter issued to AlIez Spine LLC by the Food & Drug Administration. The Company decided it could better address the FDA's concerns regarding Current Good Manufacturing Practice requirements of the Quality System without any product in the market so it could focus all of its efforts on responding to the FDA.

    Action

    Allez Spine issued a field notification beginning August 21, 2008 via FedEx to all its hospital users, distributors and field representatives informing them of their decision to recall the Allez Spine Laguna Pedicle Screw System, Allez Spine Del Mar Pedicle Screw System and the Allez Spine Cross Connectors as a result of a Warning Letter issued to AlIez Spine LLC by the Food & Drug Administration. The recall letter requested their customers to return their entire inventory of AlIez Spine manufactured products as soon as possible, gave instruction for product return and provided a contact person and telephone number for information regarding the recall.

    Distribution

    Nationwide Distribution --- including states of AZ, CA, CO, GA, IL, NV, TN, TX, & UT.

    Quantity

    6472 units for all systems