Neodent¿ GM Mini Conical Abutment — Class II medical device recall Z-0455-2019
Terminated recall by Straumann Manufacturing, Inc., reported 2018-11-21, distributed nationwide. Laser engraved label does not match with the item in the package
| Recall number | Z-0455-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Straumann Manufacturing, Inc., Andover, MA, United States |
| Recall initiated | 2018-10-02 |
| Classified | 2018-11-13 |
| Reported by FDA | 2018-11-21 |
| Terminated | 2019-01-28 |
| Distributed | Nationwide (US) |
| Quantity | 21 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 07899878026488 |
| Lot numbers | 800327510 |
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 for recall
Laser engraved label does not match with the item in the package
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0455-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.