# FDA recall Z-0455-2019

> **Straumann Manufacturing, Inc.** · Class II · device recall initiated 2018-10-02.

## 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

## Distribution

US nationwide distribution in the states of GA, TX , VA.

## Key facts

- **Recall number:** Z-0455-2019
- **Recalling firm:** Straumann Manufacturing, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-10-02
- **Report date:** 2018-11-21
- **Termination date:** 2019-01-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Andover, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0455-2019

## Citation

> AI Analytics. FDA recall Z-0455-2019. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/Z-0455-2019. Source: US FDA. Licensed CC0.

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