BEUDAMED
    FDA Enforcement Class II Ongoing

    smith&nephew TRIGEN INTERTAN 10S, REF 71675384, 10 MM X 18 CM NAIL, 130o (degrees), SET SCREW PREASSEMBLED IN NAIL

    Recall: Z-0097-2018 · Reported November 22, 2017

    Enforcement

    Recall Number
    Z-0097-2018
    Event ID
    78390
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Smith & Nephew, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 22, 2017
    Initiation Date
    October 24, 2017
    Classification Date
    November 16, 2017
    Address
    1450 E Brooks Rd, N/A, Memphis, TN, 38116-1804, United States

    Description

    smith&nephew TRIGEN INTERTAN 10S, REF 71675384, 10 MM X 18 CM NAIL, 130o (degrees), SET SCREW PREASSEMBLED IN NAIL

    Reason

    A single lot of INTERTAN 10S 10 MM X 18 CM 130 D was manufactured with the screw inserted upside down.

    Code Info

    Lot number 16LM07111

    Distribution

    US Distribution - TN, IL, CT, MO, CA., and Internationally to Italy and Germany

    Quantity

    17 units