BEUDAMED
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    ABBOTT SPINE, INC. SPINNAKER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    PathFinder Cannulated T-Handle Bone Awl, Part Number 1155-2; distributed by Abbott Spine, Inc., Austin, TX 78727.

    FDA Recall
    Terminated ·Abbott Spine·Product code NKB·April 17, 2008

    Abbott Spine Thoracolumbar Common, SpdLnk 5.5 Trans Cntr Med 43-51 mm, non-sterile, Manufactured by Abbott Spine, Inc., Austin, TX; Ref. 1302-55M. Note: This lot was not distributed in the United States. The component is used in the stabilization of constructs in the BacFix and InCompass spinal fixation systems. It is used within a temporary construct that assists normal healing and is not intended to replace normal body structures.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code KWP·September 21, 2009

    Abbott Spine PathFinder, Cannulated Poly Screwdriver II - MOD, non-sterile, Manufactured by Abbott Spine, Inc., Austin, TX; Ref. 1160-2. Usage: The screwdriver is intended to mate to the hexalobular feature of a PathFinder open polyaxial screw and threads onto the head to hold it in on-axis for implanting.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code MNI·January 12, 2009

    Pathfinder End Screw Extender Sleeve, REF 1165-10, Rx, non-sterile, sold under label Abbott Spine, Inc. Austin TX (prior to 2008) and Zimmer Spine Austin TX (7/2009 to present)

    FDA Recall
    Terminated ·Zimmer Inc.·Product code NKB·April 13, 2010

    UNIVERSAL DRIVER

    FDA Adverse Event
    Malfunction ·ABBOTT SPINE, INC.·Product code HXX·January 8, 2009

    CORTICAL OCT SCREW 4.0MM X 10MM

    FDA Adverse Event
    Malfunction ·ABBOTT SPINE, INC.·Product code KWP·May 11, 2012

    ARDIS PEEK IMPLANT 14X09X30

    FDA Adverse Event
    Malfunction ·ABBOTT SPINE, INC.·Product code MAX·May 17, 2012

    ACUFIX

    FDA Adverse Event
    Malfunction ·ABBOTT SPINE, INC.·Product code HXX·April 27, 2007

    ACUFIX

    FDA Adverse Event
    Injury ·ABBOTT SPINE, INC.·Product code KWQ·June 15, 2007

    INCOMPASS

    FDA Adverse Event
    Injury ·ABBOTT SPINE, INC.·Product code KWP·June 1, 2007

    INFIX

    FDA Adverse Event
    Injury ·ABBOTT SPINE, INC.·Product code KWQ·May 25, 2007

    INCOMPASS

    FDA Adverse Event
    Injury ·ABBOTT SPINE, INC.·Product code KWQ·June 15, 2007

    ACUFIX

    FDA Adverse Event
    Injury ·ABBOTT SPINE, INC.·Product code KWQ·April 27, 2007

    NEXLINK

    FDA Adverse Event
    Malfunction ·ABBOTT SPINE, INC.·Product code KWP·April 27, 2007

    ANTCER

    FDA Adverse Event
    Malfunction ·ABBOTT SPINE, INC.·Product code KWQ·May 11, 2007

    ACU FIX

    FDA Adverse Event
    Malfunction ·ABBOTT SPINE, INC.·Product code KWQ·May 7, 2007

    INFIX

    FDA Adverse Event
    Injury ·ABBOTT SPINE, INC.·Product code KWQ·May 25, 2007

    INCOMPASS

    FDA Adverse Event
    Injury ·ABBOTT SPINE, INC.·Product code LXH·June 15, 2007

    ANT CER

    FDA Adverse Event
    Injury ·ABBOTT SPINE, INC.·Product code JDN·June 15, 2007