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Recall Observatory FDA recall evidence

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

June 10, 2013

Class II

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

    reason.no_named_rule · v1.0.0

    One of the dental implants do not have the internal hex feature. One of the dental implants do not have the internal thread feature.