Recall Z-2208-2013 ยท DZE Implant, Endosseous, Root-Form
Biomet 3i, LLC
Osseotite Parallel Walled Certain 4mm(D)X 15mm (L) Dental Implant Product Usage: 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 reta
| Date | Sep 16, 2013 (initiated Jun 10, 2013) |
| Status | Terminated |
| Reason | One of the dental implants do not have the internal hex feature. One of the dental implants do not have the internal thread feature. |
| Root cause | Device Design |
| Action | Biomet 3i sent an Urgent: Medical Device Recall letter dated June 10, 2013 to affected customer via email, facsimile, or postal mail. The letter identified the affected product, problem, and actions to be taking. Customer were instructed to check their respective inventory for the affected product and return to Biomet 3i. Biomet 3i will issue replacement product. For questions or concerns call 1-800-342-5454. |
| Quantity | 178 |
| Distribution | Worldwide Distribution - USA Nationwide in the states of MA, CT, NJ, DE, NY, FL, OK, TX, PA, DC, IL, KS, LA, MD, CA, RI, TN, MN, and SC and the countries of Canada, Japan, Australia, Italy Germany, France, Switzerland, Apain, Brazil, Uruguay, Singapore, Dominican Republic, Taiwan, Austria, Portugal |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063341 | 3I OSSEOTITE CERTAIN DENTAL IMPLANTS Implant Innovations, Inc., Apr 30, 2007 |