BEUDAMED
    FDA Recall Terminated

    LEGION(R) FEM CONE IMPACTOR HEADS: a) REF 71441976, ID 18MM b) REF 71441977, ID 20MM c) REF 71441978, ID 22MM

    Recall: Z-2624-2017 · Initiated May 30, 2017

    Recall

    Recall Number
    Z-2624-2017
    Event Number
    77413
    Firm
    Smith & Nephew, Inc.
    FEI Number
    1020279
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 30, 2017
    Posted
    June 12, 2017
    Terminated
    December 10, 2021
    Address
    1450 E Brooks Rd, Memphis, TN, 38116-1804

    Description

    LEGION(R) FEM CONE IMPACTOR HEADS: a) REF 71441976, ID 18MM b) REF 71441977, ID 20MM c) REF 71441978, ID 22MM

    Reason

    The incorrect Loctite adhesive was used to assemble the impactor heads.

    Action

    The firm notified the consignee by email on 05/30/2017. The notice directed the consignee to inspect its inventory and locate any unused devices from the listed product and batch numbers, and quarantine them immediately. Distributors were directed to notify their customers of the field action and ensure the recall directions were followed.

    Distribution

    US distribution to TN

    Quantity

    36 units