BEUDAMED
    FDA Recall Terminated

    Posterior Acetabular Retractor-Left with Light Cord Bracket, Model #BIO-1-1050-A, and Posterior Acetabular Retractor-Right with Light Cord Bracket, Model #BIO-1-1051-A, packaged 1 retractor (left or right retractor) per plastic bag. The firm name on the label is Whiteside Biomechanics, Inc., St. Louis, MO.

    Recall: Z-0316-2007 · Initiated September 15, 2006

    Recall

    Recall Number
    Z-0316-2007
    Event Number
    36760
    Firm
    Whiteside Biomechanics
    FEI Number
    3002477077
    Product Code
    GAD
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 15, 2006
    Posted
    December 27, 2006
    Terminated
    June 11, 2008
    Address
    1000 Des Peres Road, Suite 140, St. Louis, MO, 63131

    Description

    Posterior Acetabular Retractor-Left with Light Cord Bracket, Model #BIO-1-1050-A, and Posterior Acetabular Retractor-Right with Light Cord Bracket, Model #BIO-1-1051-A, packaged 1 retractor (left or right retractor) per plastic bag. The firm name on the label is Whiteside Biomechanics, Inc., St. Louis, MO.

    Reason

    The soft tissue pin in the retractor can break off and become embedded in the tissue.

    Action

    The recalling firm was notified of the problem via a telephone call from the surgeon on 9/15/06 and the remaining retractors were placed in quarantine by the hospital. The recalling firm requested return of the retractors. The recalling firm immediately visited the one remaining hospital on 9/15/06 and picked up their inventory of six retractors.

    Distribution

    Distribution was made to two hospitals, one in MD and the other in MO.

    Quantity

    10 retractors (5 right, 5 left)