BEUDAMED
    FDA Recall Terminated

    Altrus Thermal Tissue Fusion Handpieces under the following specifications: 1) 10mm x 16 cm Catalog Number: 60-9510-001, 2) 10 mm x 23 cm Catalog Number: 60-9511-001, 3) 10 mm x 36 cm Catalog Number: 60-9512-001, 4) 5 mm x 16 cm Catalog Number 60-9520-001, 5) 5 mm x 23 cm Catalog Number 60-9521-001 and 6) 5 mm x 36 cm Catalog Number 60-9522-001. Products are packaged within cartons, 6 units per carton.

    Recall: Z-1839-2014 · Initiated February 20, 2014

    Recall

    Recall Number
    Z-1839-2014
    Event Number
    67610
    Firm
    ConMed Corporation
    FEI Number
    3001451571
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 20, 2014
    Posted
    June 20, 2014
    Terminated
    April 7, 2017
    Address
    525 French Road, Utica, NY, 13502

    Description

    Altrus Thermal Tissue Fusion Handpieces under the following specifications: 1) 10mm x 16 cm Catalog Number: 60-9510-001, 2) 10 mm x 23 cm Catalog Number: 60-9511-001, 3) 10 mm x 36 cm Catalog Number: 60-9512-001, 4) 5 mm x 16 cm Catalog Number 60-9520-001, 5) 5 mm x 23 cm Catalog Number 60-9521-001 and 6) 5 mm x 36 cm Catalog Number 60-9522-001. Products are packaged within cartons, 6 units per carton.

    Reason

    ConMed Corporation initiated an Urgent Medical Device Correction for Altrus Thermal Tissue Fusion Handpieces due to risk of burns.

    Action

    On February 20, 2014 and February 28, 2014 ConMed Corporation distributed Urgent Medical Device Correction notices to their domestic and foreign customers via FedEx Priority. The notice was generated by ConMed for information purposes only. Customers are to ensure that the jaws of the energy vessel sealing device does not come in contact with unintended tissue, surfaces, or objects until the jaws have cooled sufficiently. Customers who have further distributed this product, please forward a copy of the correction notice to the recipient as appropriate. Customers will questions should contact ConMed Regulatory Affairs at (315) 624-3237 or by email at [email protected].

    Distribution

    Worldwide Distribution.

    Quantity

    12,653 units (10,769 domestically & 1,884 internationally)