BEUDAMED
    FDA Recall Terminated

    Peri-Loc(R) VLP 3.5 MM X 6 MM SELF-TAPPING CORTEX SCREW, QTY: (1), STERILE R, REF 71801306 Orthopedic

    Recall: Z-1854-2017 · Initiated March 9, 2017

    Recall

    Recall Number
    Z-1854-2017
    Event Number
    76729
    Firm
    Smith & Nephew, Inc.
    FEI Number
    1020279
    Product Code
    HRS
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    March 9, 2017
    Terminated
    August 21, 2019
    Address
    1450 E Brooks Rd, Memphis, TN, 38116-1804

    Description

    Peri-Loc(R) VLP 3.5 MM X 6 MM SELF-TAPPING CORTEX SCREW, QTY: (1), STERILE R, REF 71801306 Orthopedic

    Reason

    The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the labeling.

    Action

    Smith & Nephew sent an Urgent Medical First Recall Notice dated March 9, 2017, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. The letter requested the quarantine and return of the devices, and for the distributors to notify their consignees and ensure the same actions. International consignees were notified by email. Consignees with questions were instructed to contact [email protected]. For questions regarding this recall call 978-749-1440.

    Distribution

    Worldwide Distribution - US (Nationwide) Internationally to Colombia, Denmark, Finland, France, Great Britain, Italy, and Singapore

    Quantity

    1 unit