FDAFDA · Food and drugs·Recall number Z-0119-2013
Osseotite Tapered Certain Implant 5 X 10mm Model INT510 Biomet 3i Dental Implants are 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 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 October 31, 2012 · Recall initiated: August 3, 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 recalled their Osseotite Tapered Certain Implant, Model # INT510 due to a small percentage of the devices are missing the internal threading.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Biomet 3i, LLC
- Distributor
- Worldwide Distribution - USA including PA, GA, OR, KS, NY, VA, CT, NH, IL, OK, and MA and internationally to Australia, Brazil, Columbia, France, Germany, Ireland, Italy, Japan, Paraguay, Portugal, and Spain.
- Lot
- Model # INT510, Lot # 2011090751
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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