Biomet 3i, LLC: Medical Device Recall in 2012 - (Recall #: Z-0119-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

Osseotite Tapered Certain Implant 5 X 10mm Model INT510 Biomet 3i Dental Implants are intended for 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.

Product Classification:

Class II

Date Initiated: August 3, 2012

Date Posted: October 31, 2012

Recall Number: Z-0119-2013

Event ID: 63313

Reason for Recall:

Biomet 3i recalled their Osseotite Tapered Certain Implant, Model # INT510 due to a small percentage of the devices are missing the internal threading.

Status: Terminated

Product Quantity: 227

Code Information:

Model # INT510, Lot # 2011090751

Distribution Pattern:

Worldwide Distribution - USA including PA, GA, OR, KS, NY, VA, CT, NH, IL, OK, and MA and internationally to Australia, Brazil, Columbia, France, Germany, Ireland, Italy, Japan, Paraguay, Portugal, and Spain.

Voluntary or Mandated:

Voluntary: Firm initiated