Frequently Asked Questions (FAQs)
Product Complaint Form
How to report a product complaint
For implants, abutments, clinical screws, instruments and tools
At Nobel Biocare we take all product complaints very seriously. Our ultimate goal is to identify the root cause of product failures, implement countermeasures and integrate our learnings into new product developments. In order to do this and to comply with regulatory reporting requirements, we ask you to complete our product complaint form.
To submit a product complaint, please perform the following steps:
- Fill in the online product complaint form and press “Submit”.
- Open the confirmation mail you receive and print out the attached pdf with the complaint information.
- Disinfect and sterilize the product.
- If available, prepare copies of supporting documents (e.g. X-rays/photos with information that identifies the patient removed).
- Pack the product with the pdf print-out and copies of supporting documents and ship it to the customer service address stated in the confirmation mail.
Upon receipt, we will review your complaint and provide a replacement product according to our Warranty Program terms.
Disinfect and sterilize
For returns, all products retrieved from a patient must be disinfected and sterilized. Please follow the instructions below:
- Disinfection: Use agent intended for manual disinfection, e.g. orto-phtalaldehyde solution (rinse carefully and do not clean mechanically).
For USA: Steam sterilization 270°F (132°C) for four minutes when using pre-vacuum method and 15 minutes when using the gravity method. Dry for 20 to 30 minutes when using pre-vacuum method and 15 to 30 minutes when using the gravity method.
For outside USA: Temperature 132°C (270°F), max. 137°C (279°F) for three minutes (up to 20 minutes). Dry for 10 minutes in chamber.
Pack the product
Primary package/ sterilization pouch
Please write the following information on the pouch:
- Product description (e.g. NobelReplace xxxx)
- Name or initials of the sender
- Date the issue occurred
- Unique case ID as stated in the confirmation e-mail
- Label the secondary package as “Decontaminated”
Outer shipping container, preferable with registered mail
- Name and address of Customer Service Nobel Biocare (as stated in the confirmation e-mail)
- Label the shipping container as “Decontaminated”