Recall Z-1696-2018— Straumann Manufacturing, Inc.
Class II · Terminated
Class II FDA medical device recall by Straumann Manufacturing, Inc., initiated 2018-03-23, terminated 2019-05-02. FDA's recall record names no specific 510(k) clearance for this event. Product: Straumann¿ Emdogain 0.3 ml Multipack. Enamel Matrix Derivative. Article Number 075.114W. Reason: 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..
- Recalling firm
- Straumann Manufacturing, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-03-23
- Terminated
- 2019-05-02
- Firm location
- Andover, MA, United States
Product description
Straumann¿ Emdogain 0.3 ml Multipack. Enamel Matrix Derivative. Article Number 075.114W
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.