BEUDAMED
    FDA Recall Terminated

    Model Number: GNRADIOLUCENTGUIDE (Gliding Nail Radiolucent Guide), instrument set that contains one unit of each of the following instrument: 1130020-A: GNp Carbon Targeting Handle 1130021-A: GN Adapter Screw for Handle SW 10 1130022-A: GN Targeting Guide Carbon 125 1130023-A: GN Targeting Guide Carbon 135 1130060-A: GNp Drill Guide Locking No. 3 1133158-A: GN Centering Sleeve New Guide Description: Surgical instruments comprising the Gliding Nail Radiolucent Guide, supplied unsterile for use in reusable sterilization trays.

    Recall: Z-0928-06 · Initiated February 22, 2006

    Recall

    Recall Number
    Z-0928-06
    Event Number
    35054
    Firm
    Plus Orthopedics USA
    FEI Number
    3001237832
    Product Code
    KTT
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 22, 2006
    Posted
    June 2, 2006
    Terminated
    December 13, 2007
    Address
    10188 Telesis Ct, San Diego, CA, 92121-4779

    Description

    Model Number: GNRADIOLUCENTGUIDE (Gliding Nail Radiolucent Guide), instrument set that contains one unit of each of the following instrument: 1130020-A: GNp Carbon Targeting Handle 1130021-A: GN Adapter Screw for Handle SW 10 1130022-A: GN Targeting Guide Carbon 125 1130023-A: GN Targeting Guide Carbon 135 1130060-A: GNp Drill Guide Locking No. 3 1133158-A: GN Centering Sleeve New Guide Description: Surgical instruments comprising the Gliding Nail Radiolucent Guide, supplied unsterile for use in reusable sterilization trays.

    Reason

    PLUS USA has been informed by PLUS AG that the accuracy of the instrument set may be affected in some cases. It is possible that in rare cases where patients have sclerotic (excessively hardened or firm) bone, that components may deform under application of force as the surgeon attempts to penetrate this bone with the instruments.

    Action

    There were a total of five (5) radiolucent guide instrument sets affected by the recall (imported to the U.S. between 1/23/2006 and 1/30/2006). The firm telephoned agents beginning February 22, 2006, requesting return of the devices. Returned Material Authorizations have been issued (March, 2006) for consigned inventory in the field with instructions given to remove and return affected units immediately. All returns to PLUS Orthopedics USA have been appropriately quarantined and segregated to prevent unintended use or shipment.

    Distribution

    There were a total of five (5) radiolucent guide instrument sets affected by the recall (imported to the U.S. between 1/23/2006 and 1/30/2006). The 5 sets were distributed in the following states: 1) California, 2) Idaho, and 3) New York.

    Quantity

    5