Z-2158-2012 Class II Terminated
FDA device recall Z-2158-2012 was initiated by Biomet 3I, LLC on Mar 23, 2012 and is designated Class II. 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… The recall status is terminated (terminated Dec 16, 2013). Affected quantity: 240.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 15, 2012
- Initiation Date
- Mar 23, 2012
- Termination Date
- Dec 16, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 240
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.
Distribution Pattern
Worldwide Distribution -- United States, UK, France, Canada, Mexico, Poland, Lebanon and Hong Kong.
Code Information
Lot Number 2011110798
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2158-2012
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026