PlainRecalls
FDA Devices Moderate Class II Terminated

***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

Reported: August 15, 2012 Initiated: March 23, 2012 #Z-2158-2012

Product Description

***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.

Reason for Recall

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.

Details

Recalling Firm
Biomet 3i, LLC
Units Affected
240
Distribution
Worldwide Distribution -- United States, UK, France, Canada, Mexico, Poland, Lebanon and Hong Kong.
Location
Palm Beach Gardens, FL

Frequently Asked Questions

What product was recalled? ▼
***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.. Recalled by Biomet 3i, LLC. Units affected: 240.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 15, 2012. Severity: Moderate. Recall number: Z-2158-2012.

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