BEUDAMED
    FDA Recall Terminated

    Pulsavac Plus AC Hip Kit, Catalog #00-5150-486-01, 1 kit/package, Zimmer Orthopaedic Surgical Products, Dover, Ohio

    Recall: Z-0863-2008 · Initiated December 18, 2007

    Recall

    Recall Number
    Z-0863-2008
    Event Number
    46206
    Firm
    Zimmer Orthopaedic Surgical Products
    FEI Number
    1526350
    Product Code
    FQH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 18, 2007
    Posted
    March 6, 2008
    Terminated
    May 3, 2012
    Address
    200 W Ohio Ave, Dover, OH, 44622-9642

    Description

    Pulsavac Plus AC Hip Kit, Catalog #00-5150-486-01, 1 kit/package, Zimmer Orthopaedic Surgical Products, Dover, Ohio

    Reason

    Sterility (package integrity) compromised; The effect of a silicone stain produced during assembly operations on the sterility barrier properties of the Tyvek lids has not been validated by the firm.

    Action

    Zimmer notified their customers via an Urgent Device Recall letter dated January 8, 2008. The letter requests each customers to inventory their stock. If any recalled product is located the customer is to notify Zimmer via fax and a replacement part will be shipped to them.

    Distribution

    Worldwide-USA, forty-two international and one Canadian account, including countries of Singapore, Hong Kong, Lebanon, Finland, Australia, Japan, Israel, Korea, Saudi Arabia, Dubai, Denmark, Czech Republic, Guatemala, Brazil, Taiwan, China, Nicaragua, Virgin Island, Switzerland, Austria, Spain, Belgium, The Netherlands, France, Germany, Portugal, England, Sweden, India, Argentina, Italy, Chile, Thailand & Saudi Arabia

    Quantity

    8115 kits