BEUDAMED
    FDA Recall Terminated

    smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)

    Recall: Z-2163-2018 · Initiated May 4, 2018

    Recall

    Recall Number
    Z-2163-2018
    Event Number
    80125
    Firm
    Smith & Nephew, Inc.
    FEI Number
    1020279
    Product Code
    MBH
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    May 4, 2018
    Terminated
    February 22, 2019
    Address
    1450 E Brooks Rd, Memphis, TN, 38116-1804

    Description

    smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)

    Reason

    One lot of GENESIS II 13 mm tibial punches are 2 mm smaller than specification.

    Action

    The firm initiated the recall by email on 05/04/2018. Consignees are asked to inspect inventory, locate and quarantine affected, unused devices. Affected product will be returned to Smith & Nephew. All consignees are asked to complete the Response Form, even if they do not have product to return.

    Distribution

    International only: United Arab Emirates, Spain, Mexico

    Quantity

    5 units