BEUDAMED
    FDA Recall Terminated

    LCP Volar Distal Radius Plate Extra Articular 4H HD-RT-Long, LCP Volar Distal Radius Plate 2.4 mm, Catalog number 242.465

    Recall: Z-0489-2007 · Initiated December 5, 2006

    Recall

    Recall Number
    Z-0489-2007
    Event Number
    37010
    Firm
    Synthes
    FEI Number
    3005180112
    Product Code
    HRS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 5, 2006
    Posted
    January 11, 2007
    Terminated
    February 13, 2007
    Address
    1302 Wrights Ln E, West Chester, PA, 19380-3417

    Description

    LCP Volar Distal Radius Plate Extra Articular 4H HD-RT-Long, LCP Volar Distal Radius Plate 2.4 mm, Catalog number 242.465

    Reason

    Hole is malformed, leading to reduced construct strength.

    Action

    All Sales Consultants were notified of the recall via teleconference on 12/5/06. The telephone script, part number and affected lot were communicated to the consultants during the teleconference. They were instructed to retrieve the affected product from the field.

    Distribution

    The products were shipped to medical facilities in NJ, TN, LA, and KS. The products were also shipped to sales reps in PA, SC, and CA. The product was also shipped to Canada.

    Quantity

    11 units