BEUDAMED
    FDA Recall Terminated

    Single-stage 3.5mm Healing Abutment, 4 mm, REF SYHA40, Rx Only, STERILE R, gamma irradiated, expires 2014-44, CE 0473, BIOHORIZONS, BIRMINGHAM, AL 35244. Endosseous dental implant healing abutment.

    Recall: Z-0321-2011 · Initiated September 7, 2010

    Recall

    Recall Number
    Z-0321-2011
    Event Number
    56785
    Firm
    BioHorizons Implant Systems Inc
    FEI Number
    1000592496
    Product Code
    DZE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 7, 2010
    Posted
    November 4, 2010
    Terminated
    December 13, 2010
    Address
    2300 Riverchase Ctr, Birmingham, AL, 35244-2808

    Description

    Single-stage 3.5mm Healing Abutment, 4 mm, REF SYHA40, Rx Only, STERILE R, gamma irradiated, expires 2014-44, CE 0473, BIOHORIZONS, BIRMINGHAM, AL 35244. Endosseous dental implant healing abutment.

    Reason

    Healing abutment may not fully seat on the implant.

    Action

    Consignees were notified by an Urgent: Medical Device Recall letter on 09/07/2010. The letter identified the affected product and gave some background regarding the issue. It also stated the possible impact and the cases that were not affected. Consignees were instructed to contact BioHorizons Returns & Complaints Manager Rick Self at 205-986-1250, if they have unused product from the affected lot, for a Return Authorization Number and to receive replacements. The attached Notification Certification form is to be completed and returned via fax.

    Distribution

    Worldwide Distribution -- USA, including PA, MI, NY, AL, WA, and WV, and countries of Canada and Chile.

    Quantity

    396