FDAFDA · Food and drugs·Recall number Z-2158-2012
***REF IFNT611***Full OSSEOTITE Tapered Certain Implant 6 x 11.5mm***Sterile by radiation***Rx Only***BIOMET 3i Dental Iberica S.L. WTC Almeda Park, Ed, 1, Planta 1 Pl. de la Pau s/n08940 Cornella de Llobregat (Barcelona) Spain. Lot #2011110798. Intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully endentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridge work and to retain over dentures.
Published August 15, 2012 · Recall initiated: March 23, 2012
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
Biomet 3i is recalling their product Full Osseotite Tapered Certain Implant IFNT611. The depth of the implant's internal hex is too shallow. The condition, if present, may prevent the driver; cover screw or abutment from fully engaging the implant.
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 -- United States, UK, France, Canada, Mexico, Poland, Lebanon and Hong Kong.
- Lot
- Lot Number 2011110798
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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