BEUDAMED
    FDA Enforcement Class II Terminated

    Excella II Polyaxial Pedicle Screw used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic deformities of the thoracic, lumbar, and sacral spine:

    Recall: Z-0644-2018 · Reported February 28, 2018

    Enforcement

    Recall Number
    Z-0644-2018
    Event ID
    78946
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Innovasis, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 28, 2018
    Initiation Date
    January 8, 2018
    Classification Date
    February 20, 2018
    Termination Date
    February 27, 2018
    Address
    614 E 3900 S, N/A, Salt Lake City, UT, 84107-1902, United States

    Description

    Excella II Polyaxial Pedicle Screw used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic deformities of the thoracic, lumbar, and sacral spine:

    Reason

    Nine lots of 8.5 mm Polyaxial Pedicle Screws are at risk of breakage.

    Code Info

    Catalog/Part No.: E2S8530, E2S8535, E2S8540, E2S8545, E2S8550, E2S8555, E2S8560 with Lot Number: 1101 and Catalog/Part No.: E28540, E28545 with Lot Number: 1201. Each of these parts is engraved with part number and lot number.

    Distribution

    United States

    Quantity

    1,010 parts