BEUDAMED
    FDA Recall Terminated

    Lone Star Medical Products, Inc. 1100 Series Aluminum Retractor Rings, model #1110; manufactured by Lone Star Medical Products, Inc.

    Recall: Z-0214-2007 · Initiated October 6, 2004

    Recall

    Recall Number
    Z-0214-2007
    Event Number
    36592
    Firm
    Lone Star Medical Products, Inc
    FEI Number
    1627186
    Product Code
    GAD
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 6, 2004
    Posted
    November 28, 2006
    Terminated
    December 22, 2006
    Address
    11211 Cash Rd, Stafford, TX, 77477

    Description

    Lone Star Medical Products, Inc. 1100 Series Aluminum Retractor Rings, model #1110; manufactured by Lone Star Medical Products, Inc.

    Reason

    Ni-Cr Plated 1100 Series Retractors with a chromium finish were replaced by Retractors with a hard-anodized finish after complaints of peeling were received.

    Action

    For domestic customers, the firm sent product replacement letters to customers (as listed on the firm's invoices), and hospital operating room personnel on October 6, 2004. On November 8, 2004, a faxed letter was sent to the Purchasing/Materials Management Department of all customers. From November 9 through November 12, 2004, a phone call drive was conducted to contact appropriate individuals for each customer. For international customers, the firm notified distributors and obtained end user details from them. End users were then contacted and communicated with regarding the product replacement. In addition, the firm utilized its Summer and Fall 2004 newsletters to communicate the product replacement information. Customers were encouraged to return NiCr coated products for a hard-anodized coated replacement product.

    Distribution

    World wide, including USA, Denmark, Germany, Finland, France, Taiwan, Canada, South Korea, New Zealand, Hong Kong, Italy, England, Australia, Saudi Arabia, South Africa and Singapore.

    Quantity

    31 units.