BEUDAMED
    FDA Enforcement Class II Terminated

    LEGION(R) TIB CONE IMPACTOR HEADS: a) REF 71441972, ID 24MM b) REF 71441971, ID 22MM c) REF 71441973, ID 26MM d) REF 71441974, ID 28MM e) REF 71441975, ID 30MM

    Recall: Z-2625-2017 · Reported July 5, 2017

    Enforcement

    Recall Number
    Z-2625-2017
    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) TIB CONE IMPACTOR HEADS: a) REF 71441972, ID 24MM b) REF 71441971, ID 22MM c) REF 71441973, ID 26MM d) REF 71441974, ID 28MM e) REF 71441975, ID 30MM

    Reason

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

    Code Info

    Lot numbers: a) 16HGA0040 b) 16JGA0003 c) 16JGA0005 d) 16JGA0006 e) 16JGA0007

    Distribution

    US distribution to TN

    Quantity

    46 units