Z-0119-2013 Class II Terminated
FDA device recall Z-0119-2013 was initiated by Biomet 3I, LLC on Aug 3, 2012 and is designated Class II. Reason for recall: Biomet 3i recalled their Osseotite Tapered Certain Implant, Model # INT510 due to a small percentage of the devices are missing the internal threading. The recall status is terminated (terminated Dec 20, 2012). Affected quantity: 227.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 31, 2012
- Initiation Date
- Aug 3, 2012
- Termination Date
- Dec 20, 2012
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 227
Product Description
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.
Reason for Recall
Biomet 3i recalled their Osseotite Tapered Certain Implant, Model # INT510 due to a small percentage of the devices are missing the internal threading.
Distribution Pattern
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.
Code Information
Model # INT510, Lot # 2011090751
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0119-2013
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026