Z-2207-2013 Class II Terminated
FDA device recall Z-2207-2013 was initiated by Biomet 3I, LLC on Jun 10, 2013 and is designated Class II. Reason for recall: One of the dental implants do not have the internal hex feature. One of the dental implants do not have the internal thread feature. The recall status is terminated (terminated Nov 6, 2014). Affected quantity: 215.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 25, 2013
- Initiation Date
- Jun 10, 2013
- Termination Date
- Nov 6, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 215
Product Description
Osseotite 2 Certain Prevail 5mm(D)X 4.1mm (P) X X 11.5mm (L) Dental Implant Product Usage: 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
One of the dental implants do not have the internal hex feature. One of the dental implants do not have the internal thread feature.
Distribution Pattern
Worldwide Distribution - USA Nationwide in the states of MA, CT, NJ, DE, NY, FL, OK, TX, PA, DC, IL, KS, LA, MD, CA, RI, TN, MN, and SC and the countries of Canada, Japan, Australia, Italy Germany, France, Switzerland, Apain, Brazil, Uruguay, Singapore, Dominican Republic, Taiwan, Austria, Portugal, and the United Kingdom.
Code Information
XIIOS5411
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2207-2013
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026