BTI Biotechnology Institute Complaints Policy

The ultimate goal of BTI Biotechnology Institute S.L. is to identify the root cause of product failures, implement corrective measures, and integrate what has been learned into the development of new products.

In order to comply with applicable regulatory requirements, customers must correctly complete the product complaint form, providing all personal and contact information, as well as a description of the incident, which should be as complete and accurate as possible in order to carry out the corresponding analysis of the cause that gave rise to the complaint.

Shipping conditions for reported products

Deadlines for complaints

Complaints will not be considered if they are submitted more than two months after the date on which the incident was detected. No more than two weeks should elapse between the date on which the online complaint form is completed and the date on which the product is shipped.

Requirements for analysing the incident

For incidents related to implants, it is mandatory to attach CBCT images and/or X-rays (panoramic and periapical) taken before and after placement. The product must always be attached.

In the case of incidents related to prosthetic components, it is mandatory to attach periapical X-rays taken at the time of placement, to verify their fit, and from the check-up prior to the incident. It will always be necessary to attach the product, except in the case of prostheses, where it will be sufficient to attach an image (in .jpg format) of the prosthesis.

For all other PRGF-ENDORET®, APNIA®, and BTI SCAN® software components, it will be necessary to attach documents (in formats such as .jpg, .png, mp4, .pdf, etc.), in which the incident can be clearly seen.

Disinfection and sterilisation

To prevent biological contamination, surgical instruments, implants and prosthetic components must always be sent disinfected and sterilised. In the case of products that cannot be sterilised, such as the PTD2 pipette used for PRGF-ENDORET®, it is sufficient to attach an image of the product if it has been used, or to send it bagged if the incident occurred prior to use.

Disinfection and sterilisation instructions:

  • Disinfection: use an agent intended for manual disinfection.
  • Sterilisation:
    1. Place the instruments in bags suitable for sterilisation and seal according to the manufacturer's instructions. Ensure that the bag is large enough so that there are no areas of tension that could cause the bag to break and result in loss of sterility.
    2. Place the bags in a pre-vacuum autoclave with the paper facing upwards or to the sides, without exceeding the maximum load indicated by the manufacturer and without stacking.
    3. Sterilise at 134ºC for 6 minutes. The colour change of the indicator on the bags will show that sterilisation has been successful.
    4. Once the sterilisation cycle is complete, allow the bags to dry and cool inside the autoclave, then store them in a dry and closed place.

Important: : it is necessary to use a sterilisation bag and ensure that the indicator on the bag shows that it has undergone a correct sterilisation cycle. The bag must indicate the reference of the product it contains.

Shipping conditions

Pack the product together with the signed PDF printout in the corresponding section and copies of supporting documentation, and send it to the local Customer Service address, indicating your contact details and shipping address. Use a box or padded envelope as packaging for the shipment.

Name and shipping address:

Customer Service, BTI Biotechnology Institute S.L.

15 San Antonio Street, 5th Floor | 01005 Vitoria-Gasteiz | Álava, Spain

Tel: +34 945 140 024 | Fax: +34 945 135 203

Important: BTI Biotechnology Institute is not responsible for lost shipments. Please use a shipping method that allows tracking.

Once we have received the product with the form at our offices, we will assess that:

  • The product complained about corresponds to the product sent
  • The product belongs to BTI Biotechnology Institute
  • The material complies with sterilisation conditions
  • The form has all fields completed with complete information for analysis
  • The date of the incident does not exceed 2 months

If these requirements are not met, the product will not be analysed and the complaint will be rejected for not complying with the conditions stipulated in this document.

Finally, once the complaint has been analysed, if the terms of our warranty programme are met, the replacement of the product will be assessed, including the shipping costs from BTI to the professional.

The warranty programme is available in your customer area.