Biomet 3i, LLC: Medical Device Recall in 2016 - (Recall #: Z-2478-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

IOL Titanium Temporary Cylinder Dental implants

Product Classification:

Class II

Date Initiated: November 25, 2015

Date Posted: August 24, 2016

Recall Number: Z-2478-2016

Event ID: 73184

Reason for Recall:

Pouches may not have been sealed during packing.

Status: Terminated

Product Quantity: 1, 648,273 devices (all products subject to this recall)

Code Information:

Item: IOLTC

Distribution Pattern:

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

Voluntary or Mandated:

Voluntary: Firm initiated