BEUDAMED
    FDA Recall Terminated

    smith&nephew Mini-Fragment Plating System, VLP(R) Mini-Mod Small Bone Plating System, EVOS(R) Mini Plating system, 2.0MM STOUT STRAIGHT PLATE, 8 HOLE VLP(R) MIN-MOD, REF 74442030, QTY: (1), STERILE R Bone plates and bone screws from the Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System (VLP MINI-MOD) are intended for use in internal fixation of small bones and small bone fragments and non-load bearing stabilization and reduction of bone fragments in long bones.

    Recall: Z-0397-2018 · Initiated December 11, 2017

    Recall

    Recall Number
    Z-0397-2018
    Event Number
    78826
    Firm
    Smith & Nephew, Inc.
    FEI Number
    1020279
    Product Code
    HRS
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    December 11, 2017
    Terminated
    June 22, 2018
    Address
    1450 E Brooks Rd, Memphis, TN, 38116-1804

    Description

    smith&nephew Mini-Fragment Plating System, VLP(R) Mini-Mod Small Bone Plating System, EVOS(R) Mini Plating system, 2.0MM STOUT STRAIGHT PLATE, 8 HOLE VLP(R) MIN-MOD, REF 74442030, QTY: (1), STERILE R Bone plates and bone screws from the Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System (VLP MINI-MOD) are intended for use in internal fixation of small bones and small bone fragments and non-load bearing stabilization and reduction of bone fragments in long bones.

    Reason

    Devices, incorrectly labeled as a VLP MINI-MOD 2.0MM STRAIGHT PLATE 8 HOLE, contained a VLP MINI-MOD 2.0MM STOUT PLATE 8 HOLE and vice versa

    Action

    The firm, Smith & Nephew, Inc., sent an "Urgent Medical Device Recall Notice" letter dated December 11, 2017 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to inspect your inventory, locate unused devices and quarantine immediately; if you are a distributor, you must notify your customers of the field action and ensure that these actions are carried out; return product, and complete and return the response form by email to [email protected] or fax to 901-566-7975 even if you have not product to return. If you have any questions or concerns regarding this recall please contact [email protected] or call 901-566-7084.

    Distribution

    US Distribution to states of: MI, GA, and OH.

    Quantity

    2 units