BEUDAMED
    FDA Recall Terminated

    Zimmer PERSONA Distal Valgus Alignment Guide, Nonsterile. orthopedic surgical instrument. The device sets the proper Varus/Valgus alignment of a patient's knee prior to the initial femoral resection cut being made.

    Recall: Z-2543-2014 · Initiated July 30, 2014

    Recall

    Recall Number
    Z-2543-2014
    Event Number
    68801
    Firm
    Zimmer, Inc.
    FEI Number
    1000220733
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 30, 2014
    Posted
    August 22, 2014
    Terminated
    March 6, 2015
    Address
    1800 W Center St, Warsaw, IN, 46580-2304

    Description

    Zimmer PERSONA Distal Valgus Alignment Guide, Nonsterile. orthopedic surgical instrument. The device sets the proper Varus/Valgus alignment of a patient's knee prior to the initial femoral resection cut being made.

    Reason

    Persona Distal Valgus Alignment guide collet locks are seizing in the 'unlocked' position.

    Action

    An Urgent Medical Device Correction letter dated, July 31, 2014, was issued to consignees. The letter identified the affected product, the problem, the risks, and responsibilities. Risk managers and surgeons are to review the notification and the updated surgical technique provided in Attachment 1; as well as, ensure that all affected personnel are aware of the contents. Questions or concerns should be directed to Zimmer customer call center at 1-877-946-2761.

    Distribution

    Worldwide Distribution -- United States, including Puerto Rico; and, to the countries of Australia, Austria, Japan, Belgium, Italy, Switzerland, India, Germany, Spain, France, Israel, Netherlands, Saudi Arabia, South Africa & Canada.

    Quantity

    2,248 units