BEUDAMED
    FDA Enforcement Class II Terminated

    Sigmoid Notch, Radial Plate, Small, Sterile, Do Not Reuse, Rx Only. Intended for replacement of the distal radio-ulnar joint following ulnar head resection arthroplasty.

    Recall: Z-2430-2015 · Reported August 26, 2015

    Enforcement

    Recall Number
    Z-2430-2015
    Event ID
    71676
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Howmedica Osteonics Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 26, 2015
    Initiation Date
    June 24, 2015
    Classification Date
    August 20, 2015
    Termination Date
    April 29, 2016
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2006, United States

    Description

    Sigmoid Notch, Radial Plate, Small, Sterile, Do Not Reuse, Rx Only. Intended for replacement of the distal radio-ulnar joint following ulnar head resection arthroplasty.

    Reason

    Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging integrity (sterile barrier) of the packaging type KIT I may potentially be compromised by transportation.

    Code Info

    Part Number: 390-0305 (Sigmoid Notch Radial Stem, Small) - Lot #'s 18362, 22834401 and 23852901; Part Number: 390-0307 (Sigmoid Notch Radial Stem, Large) - Lot #'s 18728, 18815, 18816, 18817, 23834501 and 23853001

    Distribution

    Worldwide Distribution.

    Quantity

    16992 total