BEUDAMED
    FDA Recall Terminated

    BIOMET 3i GS300 GOLD SLOTTED SCREW-3mm, STERILE, Rx Only. Made in USA. Lots 868517, 865348, and 868515. BIOMET 3i, 4555 Riverside Dr., Palm Beach Gardens, FL.

    Recall: Z-1956-2010 · Initiated October 6, 2009

    Recall

    Recall Number
    Z-1956-2010
    Event Number
    54371
    Firm
    Biomet 3i, LLC
    FEI Number
    1038806
    Product Code
    DZL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 6, 2009
    Posted
    July 6, 2010
    Terminated
    August 30, 2010
    Address
    4555 Riverside Dr, Palm Beach Gardens, FL, 33410-4200

    Description

    BIOMET 3i GS300 GOLD SLOTTED SCREW-3mm, STERILE, Rx Only. Made in USA. Lots 868517, 865348, and 868515. BIOMET 3i, 4555 Riverside Dr., Palm Beach Gardens, FL.

    Reason

    Biomet 3i, Palm Beach Gardens, FL is recalling their Gold Slotted Retaining Screw 3MM, Model Number GS300. Product is Out Of Specification - product was manufactured with a material not specified for use in this product.

    Action

    Each US customer was contacted by telephone using a prepared phone script. Following telephone contact, Biomet 3i performed a follow-up of each call with a faxed letter. International customers were first notified by e-mail then by fax letter. Each customer was instructed to check their respective inventory for the affected product and corresponding lot number. They were then requested to fax back a response form to Biomet 3i Regulatory Services to provide feedback concerning their inventory. They were also instructed to return the affected product to Biomet 3i. Questions or concerns are directed to Kelly Taylor at the firm at 561-776-6700.

    Distribution

    Product was distributed to 3 distributors, 14 direct consumer/users. Product was distributed in Japan, Spain, Switzerland, Uruguay, Paraguay, Mexico, France, Netherlands, Australia, and in the US in KY, DC, IL, RI, MA, NJ and TX.

    Quantity

    495 screws