# FDA recall Z-1693-2018

> **Straumann Manufacturing, Inc.** · Class II · device recall initiated 2018-03-23.

## Product

Straumann¿ Emdogain 0.15 ml 5-Pack. Enamel Matrix Derivative. Article Number 075.098W

## Reason for recall

A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product.

## Distribution

Distributed US Nationwide and Puerto Rico.

## Key facts

- **Recall number:** Z-1693-2018
- **Recalling firm:** Straumann Manufacturing, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-03-23
- **Report date:** 2018-05-16
- **Termination date:** 2019-05-02

- **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-1693-2018

## Citation

> AI Analytics. FDA recall Z-1693-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-1693-2018. Source: US FDA. Licensed CC0.

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