BEUDAMED
    FDA Enforcement Class II 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 · Reported December 4, 2013

    Enforcement

    Recall Number
    Z-0401-2014
    Event ID
    66723
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Synthes USA HQ, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    December 4, 2013
    Initiation Date
    May 29, 2013
    Classification Date
    November 26, 2013
    Termination Date
    May 21, 2015
    Address
    1302 Wrights Ln E, N/A, West Chester, PA, 19380-3417, United States

    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.

    Code Info

    part 04.124.406S, lot 3771678.

    Distribution

    US Distribution in Colorado.

    Quantity

    1