Recall Z-1703-2010 ยท DZE Implant, Endosseous, Root-Form
3m Imtec Corporation
S1813OB 1.8X13mm Sendax MDI Mini Dental Implant O-Ball Prosthetic Head
| Date | May 27, 2010 (initiated May 14, 2010) |
| Status | Terminated |
| Reason | Product has Incorrect size Labeling. Actual length is 13mm. One label is correct, and one states 10mm. |
| Root cause | Packaging process control |
| Action | IMTEC notified consignees by phone on May 14, 2010 and by Certified Letter dated May 14, 2010. |
| Quantity | 189 Implants |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031106 | IMTEC SENDAX MDI AND MDI PLUS ENDOSSEOUS IMPLANT, MODELS OB-XX, SH-XX, MOB-22, MSH-XX Imtec Corp., Aug 12, 2003 |