FDAFDA · Food and drugs·Recall number Z-1828-2012
Implant, Dental, Endosseous, Acid Etched, ICE, Osseotite, Internal Connection. . Product is labeled in part: "***Certain 3.25, 13***REF IOSM313 LOT*** OSSEOTITE Certain Implant***3.25 x 13mm***CE 0086***Use by yyyy-mm***Sterile by radiation*** STERILE R***Do not re-sterile***RX only Caution: Law prohibits dispensing without prescription***do not use if package is damaged***do not reuse***consult instructions for use***Sterile unless package is opened or damaged.*** Product Usage: The BIOMET 3i Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means of prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridgework and to retain over dentures.
Published June 27, 2012 · Recall initiated: November 4, 2011
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
On November 3, 2011 Biomet 3i, Palm Beach Gardens, FL initiated a recall of their Osseotite Certain Implant, Model # IOSM313, Lot #2010111529. Dental implant lot may not have an internal thread.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Biomet 3i, LLC
- Distributor
- Worldwide Distribution - US(nationwide) and the countries of: Brazil, Canada, Columbia, Italy, Lebanon, Spain, Switzerland, and UK.
- Lot
- Lot #2010111529
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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