Recalling Firm / Manufacturer

Biomet 3i

Product

Product is labeled as LTX XP Miniplant, Dental Implant, Sterile.

Code Information

Model No. LTX3211 - Packaged Lot No. 606199 Model No. LTX3213 - Packaged Lot No. 606191

Reason of Recall

The LTX XP Miniplant, BIOMET 3i dental implant, was labeled incorrectly. The 13MM implants were labeled and packaged as 11.5MM implants and 11.5MM implants were labeled and packaged as 13MM implants.

Date Recall Initiated

August 03, 2007

Action

International customers were contacted first by e-mail , then by fax letter 08/03/2007. Firm Initiated recall is ongoing.

Contact

Asnan Medical Services
01 / 4621613

Source of Information

U.S. FDA

SFDA Comments

SFDA urges all hospitals that have devices subjected to recall, to contact the company.