BEUDAMED
    FDA Recall 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 · Initiated October 20, 2015

    Recall

    Recall Number
    Z-0373-2016
    Event Number
    72655
    Firm
    Smith & Nephew, Inc.
    FEI Number
    1020279
    Product Code
    HRS
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    October 20, 2015
    Posted
    December 4, 2015
    Terminated
    September 21, 2016
    Address
    1450 E Brooks Rd, Memphis, TN, 38116-1804

    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.

    Action

    Distributors, notified by Fed- Ex on 10/20/2015, were asked to quarantine the product and return it.

    Distribution

    International only Germany, Japan, Russia

    Quantity

    9 units