Follow-up on Quality - Withdrawal - Recall

The Seller has implemented a material vigilance procedure for medical devices in accordance with legal requirements.

The Client agrees to communicate to the Seller, WITHOUT DELAY, any incident and risk of incident of which he might be aware concerning a medical device delivered by the Seller. If the Client reports the incident or risk of incident, he will also inform the Seller WITHOUT DELAY. The Client agrees to collect and communicate to the Seller all the information requested by the latter concerning the incident or risk of incident.

If the Seller identifies an incident or risk of incident concerning a medical device delivered to the Client, he agrees to inform the Client as soon as possible. The Client agrees to collect and communicate to the Seller all the information requested by the latter concerning the incident or risk of incident.

If the Seller informs the Client of a withdrawal or recall measure, the Client agrees to :

• Communicate to the Seller all the information and documents requested by the latter
• Implement all measures requested by the Seller and promptly send the requested supporting documents

In the event of withdrawal or recall of the products, the Client first agrees to store the affected products until recovery or destruction order by the Seller.

If the Seller requests the recovery of products subject to withdrawal or recall, the transport will be, at the Seller's choice:

• Either organized by the Seller at his expense and under his responsibility
• Or organized by the Client at his advanced expense and under the Seller's responsibility. The costs will be invoiced to the Seller upon the Client's justification.

If the Seller requests the recovery of products subject to withdrawal or recall, the destruction will be, at the Seller's choice:

• Either organized by the Seller at his expense
• Or organized by the Client at his advanced expense and according to the procedures detailed by the Seller. The costs will be invoiced to the Seller upon the Client's justification. The Client agrees to communicate to the Seller the destruction supporting documents requested by the latter.

The products subject to recovery or destruction may, at the Seller's choice:

• Be credited based on the ex-VAT purchase price invoiced to the Client
• Be replaced by an identical product from another batch
• Be replaced by a similar product with the Client's agreement

THE ADHERENCE TO THESE RULES IS AN ESSENTIAL CONDITION FOR THE SELLER. IN THE EVENT OF NON-COMPLIANCE WITH THESE REQUIREMENTS BY THE CLIENT, THE SELLER RESERVES THE RIGHT TO REFUSE ANY FURTHER ORDERS.