BEUDAMED
    FDA Recall Terminated

    ***REF IOSS511***OSSEOTITE Certain Implant 5 x 11.5mm***LOT 910695***Sterile using Radiation***Rx Only***BIOMET 3i Dental Iberica S.L.WTC Almeda Park, Ed, 1, Planta 1 Pl. de la Pau s/n 08940 Cornella de Llobregat (Barcelona) Spain***Biomet 3i Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment. The Thread form titanium screws (cylindrical dental implants) designed to be placed into mandibular or maxillary jaws in order to affix a dental prosthesis (edentulous or partially edentulous segments) that replaces 1 or more missing teeth.

    Recall: Z-0171-2012 · Initiated November 18, 2010

    Recall

    Recall Number
    Z-0171-2012
    Event Number
    58766
    Firm
    Biomet 3i, LLC
    FEI Number
    1038806
    Product Code
    DZE
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 18, 2010
    Posted
    November 8, 2011
    Terminated
    November 9, 2011
    Address
    4555 Riverside Dr, Palm Beach Gardens, FL, 33410-4200

    Description

    ***REF IOSS511***OSSEOTITE Certain Implant 5 x 11.5mm***LOT 910695***Sterile using Radiation***Rx Only***BIOMET 3i Dental Iberica S.L.WTC Almeda Park, Ed, 1, Planta 1 Pl. de la Pau s/n 08940 Cornella de Llobregat (Barcelona) Spain***Biomet 3i Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment. The Thread form titanium screws (cylindrical dental implants) designed to be placed into mandibular or maxillary jaws in order to affix a dental prosthesis (edentulous or partially edentulous segments) that replaces 1 or more missing teeth.

    Reason

    The product may contain a manufacturing defect, that if present, may prevent the driver; cover screw or abutment from fully engaging the implant.

    Action

    The firm sent an Urgent: Medical Device Recall letter, dated November 2010, to notify customers that received the Osseotite Certain Implant (IOSS511) of the problem. The customers were instructed to return the unopened device(s) to Biomet 3i for replacement. If customers notice an issue, they were to contact Customer Service at 1-800-342-5454 for assistance. Customers were to respond via fax and return the implant(s) to BIOMET 3i using the address and incident number provided. Customers with questions or concerns were instructed to contact Mark Mashburn at 561-776-6906.

    Distribution

    Worldwide Distribution -- USA , BR, JP, TW, CA, Germany, and Guam.

    Quantity

    241