BEUDAMED
    FDA Enforcement Class II Terminated

    Arthrosurface 25&30mm 10.5x28mm Taper Post Fixation Component; Catalog Number: 6105-0028, Pat Number 1105-0028. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.

    Recall: Z-1110-2015 · Reported February 18, 2015

    Enforcement

    Recall Number
    Z-1110-2015
    Event ID
    69723
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Arthrosurface, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 18, 2015
    Initiation Date
    November 24, 2014
    Classification Date
    February 12, 2015
    Termination Date
    March 27, 2015
    Address
    28 Forge Pkwy, N/A, Franklin, MA, 02038, United States

    Description

    Arthrosurface 25&30mm 10.5x28mm Taper Post Fixation Component; Catalog Number: 6105-0028, Pat Number 1105-0028. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.

    Reason

    Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications.

    Code Info

    Catalog Number: 6105-0028, Part Number 1105-0028

    Distribution

    Worldwide Distribution - USA nationwide. Internationally distributed to Europe, Canada, and Australia. Only products in US affected by this recall.

    Quantity

    136