BEUDAMED
    FDA Recall Terminated

    Vanguard Distal Femoral Augment 75 X 5 RL/LM Product Usage: Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. Correction of varus, valgus, or posttraumatic deformity. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. The device is a single use implant intended for implantation with bone cement.

    Recall: Z-0111-2017 · Initiated August 9, 2016

    Recall

    Recall Number
    Z-0111-2017
    Event Number
    75237
    Firm
    Zimmer Biomet, Inc.
    FEI Number
    1825034
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    August 9, 2016
    Posted
    October 18, 2016
    Terminated
    May 17, 2017
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    Description

    Vanguard Distal Femoral Augment 75 X 5 RL/LM Product Usage: Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. Correction of varus, valgus, or posttraumatic deformity. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. The device is a single use implant intended for implantation with bone cement.

    Reason

    Contents of the package do not match the product labeling. Product is labeled: Vanguard Distal Femoral Augment 75 X 5 RL/LM Carton contains: Vanguard Distal Femoral Augment 75 X 5 LL/RM Risks: Adverse health outcomes that could occur as a result of this event are a delay less than 30 minutes and a different size augment being used to complete the procedure. As the augment will not assemble with femoral component due to its shape, it would be easily identified during surgery.

    Action

    On 8/9/2016, URGENT MEDICAL DEVICE RECALL REMOVAL notifications were sent to the affected consignees via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. If after reviewing this notice you have further questions or concerns please call 1-800-348-9500 ext. 1251 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of operating hours will receive a call back the next business day. Alternatively, your questions may be sent by email to [email protected].

    Distribution

    Worldwide Distribution - US Nationwide in the states of NJ, MI, FL and the countries of Sweden and Canada.

    Quantity

    5