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U.S. Department of Health and Human Services

Enforcement Report - Week of September 25, 2013

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Product Detail

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.
Recall Number Z-2207-2013
Classification Class II
Code Info XIIOS5411
Product Distributed Qty 215
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.

Event Detail

Event Id 66204
Product Type Devices
Status Ongoing
Recalling Firm Biomet 3i, LLC
City Palm Beach Gardens
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-06-10
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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.
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