Product is Full OSSEOTITE 2 Tapered Certain Implant, Model Number XIFNT413, and size 4 x 13 mm. The product is sterile. Product provides 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 Insight

This FDA Devices action (record #Z-0297-2013) was formally reported on November 28, 2012, with the manufacturer initiating the action on September 28, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Biomet 3i, LLC is listed as the recalling firm, operating out of Palm Beach Gardens, FL. Federal records list the affected scope as 191 devices.

The documented reason for this recall is: Biomet 3i recalled Full OSSEOTITE 2 Tapered Certain Implant and Full OSSEOTITE Parallel Walled Certain Implant due to a manufacturing condition where the depth of the implant's internal hex is too shallow. This conditi… Distribution data in the federal record shows the product reached: Worldwide Distribution-USA (nationwide) including the states of VA, SC, HI, LA, OH, FL, IL, NJ, NC, CA, CT, MI, TN, AK, NH, NY, MA, GA, PA, and KY and the countries of United Kingdom, Spain, Germany, Canada, Japan, Sing…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.