Online Product Complaints

Written communications alleging deficiencies related to the identity, quality, durability, safety, efficacy or performance of the medical device after sale are considered complaints.

For implants, prosthetic material, surgical instruments, Endoret® PRGF, BTI APNIA and medical software.

Requests for replacement of material not related to product incidents will not be processed through this website.

The ultimate goal of BTI Biotechnology Institute S.L. is to identify the root cause of faults in products, to implement corrective measures and incorporate what we have learnt into the development of new products. To do this and to comply with the applicable regulatory requirements, we ask you fill in our product complaints form, following these steps:

1. Fill in the product complaints form and click on "Send". To do this, you must first fill in the general information section with your personal and contact details, then, provide a description of the incident, please be as precise as possible.
2. At the end of the request, a confirmation in PDF format will be created that contains all information regarding the complaint. Open this document.
3. Sterilise the product.
4. If available, make copies of any supporting documentation (such as x-rays or photographs together with the complaint identification number).
5. Pack the product together with a print-out of the signed PDF in the corresponding section and the copies of supporting documentation and send it to the address of your local Customer Service indicated in the "Contact details and shipping address" section.

When we receive your shipment, we will review it and provide you with a replacement product in accordance with the terms of our Guarantee Programme

NOTE: For the analysis of the complaint and, if necessary, the replacement of the product, no more than 2 weeks should elapse between the date on which the web form is completed and the date of dispatch of the product.

When sending products subject to complaint, all products recovered from a patient must be disinfected and sterilised. Follow the instructions below:

• Disinfection: Use an agent suitable for manual disinfection.

• Sterilisation:

1. Place the instruments in a suitable bag for sterilisation and seal according to the manufacturer's instructions. Ensure the bag is large enough so there is no areas of stress that could cause the bag to burst and the sterility subsequently to be lost.
2. Insert the bag into a pre-vacuum autoclave with the paper up or to the edges, without exceeding the maximum load indicated by the manufacturer and without stacking.
3. Sterilise at 134ºC for 6 minutes. The indicator on the bag will change colour to show that the sterilisation is correct.
4. Once the sterilisation cycle has finished, leave the bags to cool and dry inside the autoclave and then put them away in a closed, dry place.

Important: A sterilisation bag must be used and the indicator on the bag must show that it has been subject to a sterilisation cycle. For products that can't be sterilised, simply follow the instructions for disinfection and place the respective products into a sterilisation bag.

Sterilisation bag

Write the following information on the bag:

• Product reference

Outer packaging of shipment, via recorded delivery

• Name and address of Customer Service at BTI Biotecnology Institute S.L. (see address below)
• Use a box or a padded envelope as packaging for the shipment
• Label the packaging as "Sterilised"

BTI Biotechnology Institute S.L. cannot be held responsible for lost shipments. Use a shipping method that enables tracking.

Contact details and shipping address

BTI Biotechnology Institute S. L.

Customer Service San Antonio 15, 5º 01005 Vitoria-Gasteiz | Álava | Spain

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