FDA Device recall Z-0455-2019
Neodent¿ GM Mini Conical Abutment - Product Usage: Mini Conical Abutments are intermediary prosthetic components to be installed onto GM im…
- FDA Device
- Class II
- terminated
- Published 2018-11-21
On 2018-11-21 the FDA classified a Class II recall of Neodent¿ GM Mini Conical Abutment - Product Usage: Mini Conical Abutments are intermediary prosthetic components to be installed onto GM im… by Straumann Manufacturing, citing laser engraved label does not match with the item in the package.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0455-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-10-02 |
| Published | 2018-11-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Straumann Manufacturing |
| Distribution | US |
Product
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 indicated for screw-retained multiple-unit prostheses onto implants Article Number: 115244
Reason
Laser engraved label does not match with the item in the package
Identifiers
| code_info | Lot Number: 800327510 UDI: (01)07899878026488(11)171110(17)221110(10)800327510 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0455-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.