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 e-mail you receive and print out the attached PDF with the complaint information.
- Decontaminate the product.
- If available, prepare copies of supporting documents (e.g. X-rays/photos along with Patient ID number).
- Pack and ship the product with the PDF print-out and copies of supporting documents and ship it to your local customer service or returns department address (see section “Pack and Ship the product” below).
Upon receipt, we will review your complaint and provide a replacement product according to our Warranty Program terms.
Decontaminate the product
For returns, all products retrieved from a patient must be disinfected and sterilized. Please follow the applicable instructions below:
- Disinfection: Use agent intended for manual disinfection, e.g. ortho-phthalaldehyde 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.
IMPORTANT: A sterilization pouch must be used and the indicator on the pouch should show that it has been put through a sterilization cycle. For products which cannot be sterilized, please follow only the disinfection instructions and insert the applicable product(s) into a sterilization pouch.
Pack and ship the product
Please write the following information on the pouch:
- Product description (e.g. NobelReplace xxxx)
- Date the issue occurred
- Unique Complaint ID as stated in the confirmation e-mail
- Patient code
Outer shipping container, with registered e-mail
- Name and address of Customer Service or Returns department Nobel Biocare (see address below)
- Use a box or padded envelope as shipping container
- Label the shipping container as “Decontaminated”