BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-0097-2018 · Initiated October 24, 2017

    Recall

    Recall Number
    Z-0097-2018
    Event Number
    78390
    Firm
    Smith & Nephew, Inc.
    FEI Number
    1020279
    Product Code
    JDS
    Status
    Open, Classified
    Root Cause
    Employee error
    Initiated
    October 24, 2017
    Address
    1450 E Brooks Rd, Memphis, TN, 38116-1804

    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.

    Action

    Smith & Nephew sent an Urgent Medical Device Recall Notice dated October 24, 2017, to all affected customers. The firm requested return of the product. Please follow the instructions on the attached Response Form. For further questions, please call (978) 749-1440.

    Distribution

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

    Quantity

    17 units