Recall Z-0455-2019 ยท DZE Implant, Endosseous, Root-Form
Straumann Manufacturing, Inc.
Neodent GM Mini Conical Abutment - Product Usage: Mini Conical Abutments are intermediary prosthetic components to be installed onto GM implants to support the final prosthesis. They are provided in a rotational shape for the coupling with the prosthesis and in different gingival heights to match the variations in mucosal thickness. The GM Exact Mini Conical abutment is provided angled. They are i
| Date | Oct 2, 2018 |
| Status | Terminated |
| Reason | Laser engraved label does not match with the item in the package |
| Root cause | Employee error |
| Action | Straumann sales reps. visited each account, retrieved and returned product to Straumann USA. |
| Quantity | 21 units |
| Distribution | US nationwide distribution in the states of GA, TX , VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K163194 | Neodent Implant System - GM Line Jjgc Industria E Comercio DE Materiais Dentarios S.A., Jul 14, 2017 |