BEUDAMED
    FDA Recall Terminated

    Orthocord Suture, DePuy Mitek, a Johnson & Johnson Company; . DePuy Mitek, Inc. 325 Paramount Drive, Raynham, MA 02767 Sutures are intended for general soft tissue approximation and/or ligation.

    Recall: Z-1316-2009 · Initiated February 2, 2009

    Recall

    Recall Number
    Z-1316-2009
    Event Number
    51049
    Firm
    Ethicon, Inc. US
    FEI Number
    2210968
    Product Code
    NEW
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 2, 2009
    Posted
    May 12, 2009
    Terminated
    October 21, 2009
    Address
    Highway 22 West, Somerville, NJ, 08876

    Description

    Orthocord Suture, DePuy Mitek, a Johnson & Johnson Company; . DePuy Mitek, Inc. 325 Paramount Drive, Raynham, MA 02767 Sutures are intended for general soft tissue approximation and/or ligation.

    Reason

    Sterility Issue: The firm decided to remove the product because it cannot assure the sterility of the products due to a failure in the sterilization process.

    Action

    Urgent Voluntary Product Recall notification letters were sent via UPS Next Day Air with receipt on February 2, 2009. Letters were sent to customers, Directors of Surgical Services, Director of Risk Management, Materials Manager and Distributors. The letters requested that customers immediately discontinue use of the products with lot numbers listed. Customers are to identify and return only the boxes identified in the attached tables. The affected product should be returned to Ethicon via the pre-paid authorized shipping label. Customers that are not returning affected product should mail the enclosed business reply card to Ethicon. Customers should direct questions regarding this recall to 1-888-202-3694 or their Ethicon sales representative. 5/13/09: It was discovered that a lot of PDS II sutures that had been previously identified as affected but not distributed, were mistakenly distributed. Revised letters including this number were sent to 25 customers on 5/13/09.

    Distribution

    Worldwide Distribution -- USA, Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Greece, Hong Kong, Israel, Japan, Korea, Luxemburg, Mexico, New Zealand, Norway, Panama, Puerto Rico, Sweden, Taiwan, United Kingdom, Uruguay, and Venezuela.

    Quantity

    1,758,360 total