BEUDAMED
    FDA Enforcement Class II Terminated

    Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, RIGHT - 62 MM, STERILE R, Rx only, REF Numbers: 71863114 Bone fixation plate

    Recall: Z-0373-2016 · Reported December 16, 2015

    Enforcement

    Recall Number
    Z-0373-2016
    Event ID
    72655
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smith & Nephew, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 16, 2015
    Initiation Date
    October 20, 2015
    Classification Date
    December 4, 2015
    Termination Date
    September 21, 2016
    Address
    1450 E Brooks Rd, N/A, Memphis, TN, 38116-1804, United States

    Description

    Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, RIGHT - 62 MM, STERILE R, Rx only, REF Numbers: 71863114 Bone fixation plate

    Reason

    The devices were packaged and laser marked anatomically incorrect. The Left plates were laser marked and packaged as Right plates and the Right plates were laser marked and packaged as Left plates.

    Code Info

    Batch # 14KT47575

    Distribution

    International only Germany, Japan, Russia

    Quantity

    9 units