BEUDAMED
    FDA Recall Terminated

    Synthes 4.5 mm LCP Curved Condylar Plate Intended for buttressing multifragmentary distal femur fractures.

    Recall: Z-0409-2014 · Initiated July 30, 2013

    Recall

    Recall Number
    Z-0409-2014
    Event Number
    66418
    Firm
    Synthes USA HQ, Inc.
    FEI Number
    3005180112
    Product Code
    KTT
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    July 30, 2013
    Posted
    November 27, 2013
    Terminated
    August 31, 2015
    Address
    1302 Wrights Ln E, West Chester, PA, 19380-3417

    Description

    Synthes 4.5 mm LCP Curved Condylar Plate Intended for buttressing multifragmentary distal femur fractures.

    Reason

    The Synthes 4.5 mm LCP Curved Condylar Plate was recalled because a Straight Condylar Plate is etched with a Curved Condylar Plate part number.

    Action

    Synthes sent an Urgent Notice: Medical Device Notification letter dated October 8, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to returny any of the affect devices, call Synthes at 1-800-479-6329 to obtain a Return Authorization Number, complete the Verification Section indicating the affected product has been located, also indicate the number of devices found and note the Return Authorization Number. Return the Verification Form to: Credit/Returns Synthes 1101 Synthes Avenue Monument, CO 80132 Customers were also instructed to return the Verification Section even if they don't have the affected product. Customers with questions were instructed to call 610-719-5450 or contact their Synthes Sales Consultant. For questions regarding this recall call 610-719-5000.

    Distribution

    Worldwide Distribution - USA including ID, FL, TN, NY, LA and Internationally to Canada.

    Quantity

    13