Recall Z-1221-2007 ยท DZE Implant, Endosseous, Root-Form
Biomet 3i
Product is labeled as LTX XP Miniplant, Dental Implant, Sterile.
| Date | Sep 18, 2007 (initiated Aug 3, 2007) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Labeling mix-ups |
| Action | International customers were contacted first by e-mail , then by fax letter 08/03/2007. |
| Quantity | 240 (120 each model / lot) |
| Distribution | Product was not distributed within the U.S. Product was distributed Internationally - Brazil, Argentina, Israel, Mexico, Colombia, Korea, Taiwan, Uruguay, Italy, Chile. |
| FDA record | Open on fda.gov |