Device product
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.
Z-2207-2013
Product summary
- Firm
- Biomet 3i, LLC
- Event
- Event 66204
- Status
- Terminated
- Classification
- Class II
- Quantity
- 215
- Official record key
device-enforcement:Z-2207-2013
Official wording
Reason: One of the dental implants do not have the internal hex feature. One of the dental implants do not have the internal thread feature.
Code information: XIIOS5411
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.
Derived failure modes
-
Unknown
One of the dental implants do not have the internal hex feature. One of the dental implants do not have the internal thread feature.