BEUDAMED
    FDA Enforcement Class II Terminated

    Excella II Standard Pedicle Screw, Catalog No. E2S47525 and E2S47535, 4.75 mm x 25 mm. For spinal fixation. Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization tray as implant set.

    Recall: Z-2067-2014 · Reported July 23, 2014

    Enforcement

    Recall Number
    Z-2067-2014
    Event ID
    68781
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Innovasis, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    July 23, 2014
    Initiation Date
    July 7, 2014
    Classification Date
    July 16, 2014
    Termination Date
    August 11, 2014
    Address
    614 E 3900 S, N/A, Salt Lake City, UT, 84107-1902, United States

    Description

    Excella II Standard Pedicle Screw, Catalog No. E2S47525 and E2S47535, 4.75 mm x 25 mm. For spinal fixation. Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization tray as implant set.

    Reason

    Innovasis is recalling the Excella II Standard Pedicle Screw due to mislabeling of the size and catalog number.

    Code Info

    E2S47525 Lot 1301 and E2S47535 Lot 1301

    Distribution

    Distribution US nationwide, including TX, CA, KS, MN, and OK. Foreign distribution to Japan.

    Quantity

    32