BEUDAMED
    FDA Recall Terminated

    Stryker Biotech OP- 1 Implant is indicated for use as an alternative to autograft in recalcitrant long bone nonunions where use of autograft is unfeasible and alternative treatments have failed. Catalog Number: 100-25

    Recall: Z-2311-2008 · Initiated June 24, 2008

    Recall

    Recall Number
    Z-2311-2008
    Event Number
    48737
    Firm
    Stryker Biotech
    FEI Number
    1000513212
    Product Code
    MPW
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    June 24, 2008
    Posted
    September 20, 2008
    Terminated
    October 16, 2008
    Address
    35 South St, Hopkinton, MA, 01748-2218

    Description

    Stryker Biotech OP- 1 Implant is indicated for use as an alternative to autograft in recalcitrant long bone nonunions where use of autograft is unfeasible and alternative treatments have failed. Catalog Number: 100-25

    Reason

    Product Package Insert misprint-text offset

    Action

    Stryker Biotech notified by letter dated June 24, 2008 via UPS Certified Mail. Physician letters were mailed 30 Jun 2008 and IRB letters were mailed July 01, 2008; letters included a correctly printed package insert. Contact Judith Sernatinger at 508-416-5200 if you have questions.

    Distribution

    Nationwide

    Quantity

    803 units