BEUDAMED
    FDA Recall 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 · Initiated November 24, 2014

    Recall

    Recall Number
    Z-1110-2015
    Event Number
    69723
    Firm
    Arthrosurface, Inc.
    FEI Number
    3004154314
    Product Code
    HSD
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    November 24, 2014
    Posted
    February 12, 2015
    Terminated
    March 27, 2015
    Address
    28 Forge Pkwy, Franklin, MA, 02038

    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.

    Action

    Arthosurface sent an Urgent Medical Device Recall letter on November 24, 2014 via UPS, to all affected customers. The letter informed consignees of the recall and asked them to return two completed forms, 1. Acknowledgement & Receipt Form and 2. Inventory Record via fax, email, or mail. Customers with questions were instcted to contact their local sales representatiave or email [email protected]. For questions regarding this recall call 508-528-4604.

    Distribution

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

    Quantity

    136