BEUDAMED
    FDA Recall Terminated

    Finger Joint Implants, Silicone Models TRL-10 and TRL-20

    Recall: Z-0710-03 · Initiated January 24, 2003

    Recall

    Recall Number
    Z-0710-03
    Event Number
    25577
    Firm
    Avanta Orthopaedics, Inc.
    FEI Number
    1000519983
    Product Code
    KYI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 24, 2003
    Posted
    April 9, 2003
    Terminated
    December 1, 2004
    Address
    9369 Carroll Park Drive, Ste A, San Diego, CA, 92121

    Description

    Finger Joint Implants, Silicone Models TRL-10 and TRL-20

    Reason

    Wrong silicone elastomer used in construction.

    Action

    Recall was initiated by telephone on 1/24/2003. All customers responded by 1/28/2003. All units have been accounted for. The units have been returned. The recall is complete.

    Distribution

    States of CA and UT and to France.

    Quantity

    43