BEUDAMED
    FDA Recall Terminated

    ACT3020 Advanced Cutting technology (ACT) Twist Drill 3.0mm(D) X 20mm(L). BIOMET 3i 455 Riverside Drive, Palm Beach Gardens, FL 33410 USA. Made in Switzerland. Twist drill for preparation of osteotomy during dental implant surgical drilling procedure.

    Recall: Z-1947-2009 · Initiated June 29, 2009

    Recall

    Recall Number
    Z-1947-2009
    Event Number
    52604
    Firm
    Biomet 3i, LLC
    FEI Number
    1038806
    Product Code
    DZA
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    June 29, 2009
    Posted
    September 1, 2009
    Terminated
    January 5, 2010
    Address
    4555 Riverside Dr, Palm Beach Gardens, FL, 33410-4200

    Description

    ACT3020 Advanced Cutting technology (ACT) Twist Drill 3.0mm(D) X 20mm(L). BIOMET 3i 455 Riverside Drive, Palm Beach Gardens, FL 33410 USA. Made in Switzerland. Twist drill for preparation of osteotomy during dental implant surgical drilling procedure.

    Reason

    Some of the packages of ACT3020, drills may actually contain an ACT3220 drill.

    Action

    Consignees were notified of recall by telephone and by faxed an Urgent: Medical Device Recall letter, dated June 30, 2009. The letter stated the problem. The letter also asked customers to check their surgical kits and confirm the drill is placed in the correct space within the kit. Customers are to verify that the shank of the drill is marked as ACT3020 on one side and as 3.0 x 20mm on the opposite side. The letter also stated the clinical implications. Customers are to respond with the attached response fax and then return the drills to BIOMET 3i. Once the returned product is received, replacement drills will be sent to the customers. Questions or concerns should be directed to Kelly Taylor at 561-776-6906.

    Distribution

    Worldwide Distribution -- Korea, Netherlands, Taiwan, United Kingdom, and USA.

    Quantity

    29 units