BEUDAMED
    FDA Recall Terminated

    Specialist 2 IM Rod, Non-Sterile and associated Surgical Techniques: Sigma HP Instruments Classic Surgical Technique,0612-89-510 Sigma HP Instruments Balanced Surgical Technique, 0612-88-510 Sigma HP Instruments Fixed Reference Surgical Technique, 0612-87-510 PFC Sigma Knee Systems Primary Cruciate-Retaining & Cruciate-Substituting Procedure Surgical Technique,SP2-007 Product Usage: The SP2 IM Rod is used in both primary and revision Sigma knee procedures to align the femoral locating device and distal femoral cutting block. It is also used with the IM tibial resection. This rod is included in both the SP2 and HP instrument kits.

    Recall: Z-0971-2013 · Initiated February 5, 2013

    Recall

    Recall Number
    Z-0971-2013
    Event Number
    63973
    Firm
    DePuy Orthopaedics, Inc.
    FEI Number
    1818910
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 5, 2013
    Posted
    March 19, 2013
    Terminated
    January 6, 2014
    Address
    700 Orthopaedic Dr, Warsaw, IN, 46582-3994

    Description

    Specialist 2 IM Rod, Non-Sterile and associated Surgical Techniques: Sigma HP Instruments Classic Surgical Technique,0612-89-510 Sigma HP Instruments Balanced Surgical Technique, 0612-88-510 Sigma HP Instruments Fixed Reference Surgical Technique, 0612-87-510 PFC Sigma Knee Systems Primary Cruciate-Retaining & Cruciate-Substituting Procedure Surgical Technique,SP2-007 Product Usage: The SP2 IM Rod is used in both primary and revision Sigma knee procedures to align the femoral locating device and distal femoral cutting block. It is also used with the IM tibial resection. This rod is included in both the SP2 and HP instrument kits.

    Reason

    Potential for the IM rod to break, leaving fragments in the patient. Surgical Techniques guidance has been updated until design changes can be made to reduce likelihood of potential failure.

    Action

    DePuy Orthopaedics sent an Urgent Medical Device Correction Notice letter dated February 5, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were asked to complete and return the FAX back form to FAX 574-371-4939 or email [email protected] Questions about device correction information call Post Market Surveillance, 574-372-7333, Sales force questions call Product Specialist, 574-372-7303 and Surgeon questions DePuy's Scientific Information Office at 1-888-554-2482.

    Distribution

    Worldwide Distribution - USA Nationwide.

    Quantity

    4000; 2600 in USA