BEUDAMED
    FDA Recall Terminated

    Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER is used for buttressing multi fragmentary diatal femur fractures including: supra-condylar, intra-articular and extra articular condylar fractures, periprosthetic fractures, fractures in normal or osteopenic bone, nonunions and malunions.

    Recall: Z-0401-2014 · Initiated May 29, 2013

    Recall

    Recall Number
    Z-0401-2014
    Event Number
    66723
    Firm
    Synthes USA HQ, Inc.
    FEI Number
    3005180112
    Product Code
    JDP
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    May 29, 2013
    Posted
    November 26, 2013
    Terminated
    May 21, 2015
    Address
    1302 Wrights Ln E, West Chester, PA, 19380-3417

    Description

    Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER is used for buttressing multi fragmentary diatal femur fractures including: supra-condylar, intra-articular and extra articular condylar fractures, periprosthetic fractures, fractures in normal or osteopenic bone, nonunions and malunions.

    Reason

    A plate was inadvertently released to a sales consultant that was restricted for sale.

    Action

    Synthes sent a letter dated November 7, 2013, to the implanting surgeon to follow up on a complaint received. The firm requested any additional information the surgeon might have about the use of the plate as well as a status on the patient following use. For questions the surgeon was instructed to call 800-620-7025. For questions regarding this recall call 610-719-5000.

    Distribution

    US Distribution in Colorado.

    Quantity

    1