Assisting a global medical device company in relation to its Canadian recall

Fasken Martineau was retained to assist with various aspects relating to the Canadian recall of a medical device. Fasken Martineau advised in the design and implementation of the recall strategy and product withdrawal, including negotiation of the content of related notices to customers and the public as well as a risk mitigation strategy. Fasken Martineau also prepared internal documentation and contracts with external healthcare professional consultants. Exchanges with the Medical Devices Bureau lasted over a period of several months (up to a year) and Fasken Martineau assisted in accessing the appropriate representatives in all areas of the regulatory agency.