BEUDAMED
    FDA Enforcement Class II Terminated

    LEGION(R) FEM CONE IMPACTOR HEADS: a) REF 71441976, ID 18MM b) REF 71441977, ID 20MM c) REF 71441978, ID 22MM

    Recall: Z-2624-2017 · Reported July 5, 2017

    Enforcement

    Recall Number
    Z-2624-2017
    Event ID
    77413
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smith & Nephew, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 5, 2017
    Initiation Date
    May 30, 2017
    Classification Date
    June 23, 2017
    Termination Date
    December 10, 2021
    Address
    1450 E Brooks Rd, N/A, Memphis, TN, 38116-1804, United States

    Description

    LEGION(R) FEM CONE IMPACTOR HEADS: a) REF 71441976, ID 18MM b) REF 71441977, ID 20MM c) REF 71441978, ID 22MM

    Reason

    The incorrect Loctite adhesive was used to assemble the impactor heads.

    Code Info

    Lot numbers: a) 16HGA0031 b) 16HGA0034 c) 16HGA0035

    Distribution

    US distribution to TN

    Quantity

    36 units