BEUDAMED
    FDA Recall Terminated

    Products are various dental surgical drills packed in a sealed tray and labeled as sterile. The tray is labled as follows: 3i Implant Innovations, Inc., 4555 Riverside Drive, Palm Beach 33410 USA 561-776-6700 DT 310 LOT 3.0 mm (D) X 10.0 mm (L) STERILE

    Recall: Z-0386-04 · Initiated December 2, 2003

    Recall

    Recall Number
    Z-0386-04
    Event Number
    28092
    Firm
    Implant Innovations, Inc.
    FEI Number
    1038806
    Product Code
    DZI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 2, 2003
    Posted
    July 20, 2004
    Terminated
    October 5, 2009
    Address
    4555 Riverside Dr, Palm Beach Gardens, FL, 33410-4200

    Description

    Products are various dental surgical drills packed in a sealed tray and labeled as sterile. The tray is labled as follows: 3i Implant Innovations, Inc., 4555 Riverside Drive, Palm Beach 33410 USA 561-776-6700 DT 310 LOT 3.0 mm (D) X 10.0 mm (L) STERILE

    Reason

    The tray lid seals may be open thereby compromising the sterility barriers for the recalled lots.

    Action

    The firm notified international distributors on 12/2/2003 via e-mail and also a recall notification letter was faxed to them on 12/2/2003. They were instructed to subrecall to the health professional level. Also on 12/2/2003 all domestic accounts (health practioners) were telephoned and then faxed a recall notification letter. Each account was instructed to check their inventory, respond back by fax and to return recalled product to Implant Innovations Inc.

    Distribution

    Product was distributed to 45 Dentist/Surgeons nationwide in the US and also to 13 international Distributors in Canada, Sweden, Germany, Colombia, Spain, Switzerland, Australia, Japan, Austria, France, Poland, England and Greece.

    Quantity

    40