Recall Z-1960-2013 ยท DZE Implant, Endosseous, Root-Form
Biomet 3i, LLC
Biomet 3i Dental Implant, Parallel Walled 6mm (D) x 10mm (L)
| Date | Aug 13, 2013 (initiated May 10, 2013) |
| Status | Terminated |
| Reason | A small number of outer implant boxes may be mislabeled. The inner tray, containing the implant, is label correctly. This condition, if present and not recognized could potentially result in the dental implant not being able to be placed into the osteotomy or seated to the desired depth if placement is attempted. |
| Root cause | Labeling mix-ups |
| Action | The firm issued "Urgent Medical Device Recall" notification letters to their customers dated May 10, 2013. The notification described the issue and provided recommendations actions regarding affected product. Customers with questions may contact 1 800-342-5454. |
| Quantity | 51 |
| Distribution | Distribution to the state of Massachusetts, and the foreign countries of Australia, Belgium, Spain, Denmark, France, Luxembourg, Switzerland, Germany, Bonaire, Sweden, and Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122300 | T3 DENTAL IMPLANT Biomet 3i, Jan 30, 2013 |