BEUDAMED
    FDA Recall 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 · Initiated July 7, 2014

    Recall

    Recall Number
    Z-2067-2014
    Event Number
    68781
    Firm
    Innovasis, Inc
    FEI Number
    3004719693
    Product Code
    NKB
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    July 7, 2014
    Posted
    July 16, 2014
    Terminated
    August 11, 2014
    Address
    614 E 3900 S, Salt Lake City, UT, 84107-1902

    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.

    Action

    Distributors were notified by e-mail on 7/7/14, with attached copies of the written letter and forms to be printed, signed and returned to Innovasis. Distributors have been instructed to return all inventory in stock.

    Distribution

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

    Quantity

    32