BEUDAMED
    FDA Enforcement Class II Terminated

    Excella II Rod Cat. No.: SR 55100 5.5 x 100 mm LOT 1502 and Excella II Rod Cat. No.: SR 55110 5.5 x 110 mm LOT 1502 Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization tray as implant set. Intended for use in the non-cervical area of the spine.

    Recall: Z-0662-2016 · Reported January 27, 2016

    Enforcement

    Recall Number
    Z-0662-2016
    Event ID
    72878
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Innovasis, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 27, 2016
    Initiation Date
    December 7, 2015
    Classification Date
    January 19, 2016
    Termination Date
    April 7, 2016
    Address
    614 E 3900 S, N/A, Salt Lake City, UT, 84107-1902, United States

    Description

    Excella II Rod Cat. No.: SR 55100 5.5 x 100 mm LOT 1502 and Excella II Rod Cat. No.: SR 55110 5.5 x 110 mm LOT 1502 Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization tray as implant set. Intended for use in the non-cervical area of the spine.

    Reason

    Innovasis recalled two lots of Excella II titanium rods which were packaged using each other's labels.

    Code Info

    Catalog No.: SR55110 Lot 1502 and SR55100 Lot 1502

    Distribution

    Distributed in US -- CA; KS; OH; & TX.

    Quantity

    17 units Labeled SR55100 Lot 1502 with SR55110 rods in package