BEUDAMED
    FDA Recall Terminated

    Dental Abutment labeled in part: "4555 Riverside Drive Palm Beach Gardens, FL 33410 USA 1-800-342-5454***EDAZ , EDAZx and ILDExxx***BellaTek Zirconia Abutment Position Number: XX Abutment; Pilier; Abutment; Abutment; Pilastro; Pilar***Rx only***Non-sterile, Sterilize prior to use.***Biomet 3i Dental Iberica S.L.*** Biomet 3i Dental Abutments are intended for use as accessories to endosseous dental implants to support prostheses in edentulous or partially edentulous patients. These are intended for use to support single and multiple tooth prostheses.

    Recall: Z-1215-2014 · Initiated August 26, 2013

    Recall

    Recall Number
    Z-1215-2014
    Event Number
    66787
    Firm
    Biomet 3i, LLC
    FEI Number
    1038806
    Product Code
    NHA
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 26, 2013
    Posted
    March 17, 2014
    Terminated
    September 26, 2014
    Address
    4555 Riverside Dr, Palm Beach Gardens, FL, 33410-4200

    Description

    Dental Abutment labeled in part: "4555 Riverside Drive Palm Beach Gardens, FL 33410 USA 1-800-342-5454***EDAZ , EDAZx and ILDExxx***BellaTek Zirconia Abutment Position Number: XX Abutment; Pilier; Abutment; Abutment; Pilastro; Pilar***Rx only***Non-sterile, Sterilize prior to use.***Biomet 3i Dental Iberica S.L.*** Biomet 3i Dental Abutments are intended for use as accessories to endosseous dental implants to support prostheses in edentulous or partially edentulous patients. These are intended for use to support single and multiple tooth prostheses.

    Reason

    Reports relating to Biomet 3i's BellaTek Zirconia Dental Abutment fractures were received.

    Action

    The firm, BIOMET 3i, sent an "URGENT: Medical Device Removal - BellaTek Zirconia Abutments" letter dated August 2013 via email, facsimile or postal mail to its customers. The letter described the product, problem and actions to be taken. All customers were instructed to check their inventory for the affected product; return the abutments to BIOMET 3i for replacement and full credit; complete and return the attached Recall Return Response Form, and to advise their customers and forward a copy of the Medical Device Removal Notice and the contained recommendations. BIOMET 3i has decided to initiate a design change to mitigate the fracture risk, and consequently, will cease distribution of BellaTek Zirconia Abutments unit l the corrective actions are completed. If you have any further questions, please contact Customer Service at 1-800-342-5454 for assistance.

    Distribution

    Worldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, MI, MN, MO, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, Hawaii and Puerto Rico; and countries of: Spain, Australia, Canada, Colombia, Japan, Uruguay, Mexico, Estonia, United Kingdom, Denmark, Germany, Spain, Italy, Poland, Ireland Netherlands, France, Sweden, Portugal, Australia, France, Belgium, Switzerland, Norway, Czech Republic, France, Holland, and Luxembourg.

    Quantity

    10,454