Andover, MA, United States
Straumann Manufacturing, Inc. recalls
2 recalls recorded since 2018, most recently on 2 October 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 2 October 2018
- Terminated
- 28 January 2019
- Reason
- Laser engraved label does not match with the item in the package
- Distribution
- US nationwide distribution in the states of GA, TX , VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0455-2019
- 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 f
Terminated Class II Medical devices
- Recall started
- 23 March 2018
- Terminated
- 2 May 2019
- 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.
- Distribution
- Distributed US Nationwide and Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1694-2018, Z-1698-2018, Z-1695-2018, Z-1696-2018, Z-1697-2018, Z-1693-2018
- Straumann¿ Emdogain 015, USA. Enamel Matrix Derivative. Article Number 075.099
- Straumann¿ Emdogain 0.7 ml Multipack. Enamel Matrix Derivative. Article Number 075.116W
- Straumann¿ Emdogain 0.3 ml Multipack USA. Enamel Matrix Derivative. Article Number 075.113
- Straumann¿ Emdogain 0.3 ml Multipack. Enamel Matrix Derivative. Article Number 075.114W
- Straumann¿ Emdogain 0.7 ml Multipack USA. Enamel Matrix Derivative. Article Number 075.115
- Straumann¿ Emdogain 0.15 ml 5-Pack. Enamel Matrix Derivative. Article Number 075.098W
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.