BEUDAMED
    FDA Recall Terminated

    TRABECULAR METAL FEMORAL CONE AUGMENT - LEFT, Part Number: 00-5450-012-31. The objective of the Trabecular Metal Femoral Cone Augment is to fill and reconstruct large bone deficiencies and cavitary defects in the distal femur and to provide for a stable platform for an LCCK or Rotating Hinge Knee femoral component.

    Recall: Z-2439-2010 · Initiated July 5, 2010

    Recall

    Recall Number
    Z-2439-2010
    Event Number
    56390
    Firm
    Zimmer Inc.
    FEI Number
    1000220733
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    July 5, 2010
    Posted
    September 20, 2010
    Terminated
    December 22, 2010
    Address
    1800 W Center St, Warsaw, IN, 46580-2304

    Description

    TRABECULAR METAL FEMORAL CONE AUGMENT - LEFT, Part Number: 00-5450-012-31. The objective of the Trabecular Metal Femoral Cone Augment is to fill and reconstruct large bone deficiencies and cavitary defects in the distal femur and to provide for a stable platform for an LCCK or Rotating Hinge Knee femoral component.

    Reason

    Zimmer, Inc. has determined that there is a potential for the packages to be mislabeled. Specifically, the left femoral cone augment component may be labeled as a right and the right femoral cone augment component may be labeled as a left.

    Action

    Zimmer, Inc. sent Urgent: Device Removal letters, dated July 9, 2010, identifying the affected product and stating the issue. Specifically, the left femoral cone augment component may be labeled as a right and the right femoral cone augment component may be labeled as a left. The letter also discussed the clinical implications along with required actions. Customers are to perform a physical count of all affected product and record the data on the Inventory Return Certification Form included with the letter. In addition, customers should complete and return the Inventory Certification and User Facility/HCP Documentation Forms. Affected product along with the Inventory Return Certification Form should be returned. Zimmer, Inc. should be contacted at 1-800-613-6131 if there are any questions or need for additional information.

    Distribution

    Worldwide Distribution -- USA, Canada, Singapore, Australia, and Switzerland, Spain, UK, Sweden, and Israel.

    Quantity

    50 total