BEUDAMED
    FDA Recall Terminated

    TRIGEN (TM) L-P SCREW, 4.5 MM X 37.5 MM, TI-6AL-4V, QTY: (1), STERILE R, REF 71645437, Smith & Nephew, Inc. Memphis, TN 38116 USA orthopedic surgery

    Recall: Z-1132-2013 · Initiated March 6, 2013

    Recall

    Recall Number
    Z-1132-2013
    Event Number
    64669
    Firm
    Smith & Nephew Inc
    FEI Number
    1020279
    Product Code
    HSB
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    March 6, 2013
    Posted
    April 17, 2013
    Terminated
    August 16, 2019
    Address
    1450 E. Brooks Rd, Memphis, TN, 38116

    Description

    TRIGEN (TM) L-P SCREW, 4.5 MM X 37.5 MM, TI-6AL-4V, QTY: (1), STERILE R, REF 71645437, Smith & Nephew, Inc. Memphis, TN 38116 USA orthopedic surgery

    Reason

    One batch of 4.5 mm diameter Trigen Low-Profile Bone Screws were incorrectly anodized with a gold coating (indicating a 5 mm diameter) instead of a gray coating (indicating a 4.5 mm diameter).

    Action

    Smith & Nephew sent an Urgent Product Recall Notification letter dated March 6, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to cease use and distribution of the affected product and quarantine for return. Non-responding consignees were notified again on March 15, 2013, by email. Surgeons were to be notified by letter beginning on March 20, 2013. For questions regarding this recall call 978-749-1330.

    Distribution

    Nationwide Distribution including CA, FL, GA, MA, MI, NC, SC, OH, and MO.

    Quantity

    23 units