Warranty policy

Scope

Ziacom Implants SLU, hereinafter “ZIACOM®”, guarantees the quality of the materials, manufacture and proper functioning of its original ZIACOM®-branded products, hereinafter “ZIACOM® Product(s)”. The ZIACOM® Warranty Programme, hereinafter the “Warranty Programme”, applies to ZIACOM® Products. If a product is defective, whether before or after use, due to a failure in the material strength and/or stability of the ZIACOM® Product during the period covered by the Warranty Programme as set out in section 3, please report this immediately to ZIACOM® by following the Incident Reporting procedure set out in section 6 of this Warranty Programme. This Warranty Programme relates exclusively to the ZIACOM® Products specified in section 3 and to the clinical professional or medical practitioner responsible for the treatment, hereinafter the “User”. The handling of any Incident involving a ZIACOM® Product must be managed solely and exclusively through this Warranty Programme. By purchasing any ZIACOM® Product and participating in this Warranty Programme, the User accepts the terms and conditions set out herein.

Beneficiaries

This Warranty Programme is intended exclusively for the User and does not give rise to any liability towards third parties, in particular patients or suppliers of any kind, who are not covered by this warranty. The cover provided by the Warranty Programme ONLY covers the replacement or restitution of ZIACOM® Products with the same products that are the subject of the warranty claim or with equivalent products if the original products have been discontinued. This Warranty Programme does not, therefore, cover any associated costs that may arise from other matters.

Covered products

The Warranty Programme covers the following products for the duration set out in the table below. The warranty under this Programme does not exclude any warranties the User may have as a result of their individual agreements with ZIACOM®.

Implants	Lifetime warranty. Replacement with an implant of the same reference number or an equivalent 1
Prosthetic components	15-year warranty. Replacement with a prosthetic component of the same reference or equivalent 2

Important Excluded from this Warranty Programme are components or consumables, reused single-use items and those serving a retention function. 1 If this product has been discontinued or is no longer available on the market, it will be replaced by the product that has replaced it or another equivalent product within the ZIACOM® implant portfolio. 2 If this product has been discontinued or is no longer available on the market, it will be replaced by the product that has replaced it or another equivalent product within the ZIACOM® prosthetic components portfolio.

General Terms and Conditions

ZIACOM® will replace the defective product(s) covered by this Warranty Programme with another identical product or an equivalent product that would have replaced it had it already been discontinued. The warranty periods described above shall commence from the time of sale of the ZIACOM® Products to the User; therefore, the start date of the Warranty Programme for these products shall be that stated on the sales invoice issued to the User. The Warranty Programme shall remain valid provided that all the conditions of the Programme described below are met and reliably documented: That the user

1. Has purchased the ZIACOM® Product directly and that this product was purchased through an official ZIACOM® sales channel.
2. Has correctly selected the model and type of implant for the surgical technique used and the planned implant treatment
3. Has fully documented the patient’s consent.
4. Must have used ZIACOM® Products exclusively throughout the entire treatment and, under no circumstances, must these have been modified or combined with elements or components from other manufacturers.
5. Must have carried out and documented all the periodic check-ups established for the treatment on the scheduled dates, verifying that the patient maintains good oral hygiene.
6. You must have consulted and complied with all protocols, working procedures and instructions for use relating to the ZIACOM® products used during the treatment—both surgical and prosthodontic—which were in force at the time the treatment was carried out.
7. Have selected and correctly applied the appropriate and clinically accepted dental techniques for carrying out dental implant treatments before, during and after treatment.
8. Have notified and completed the form for the ZIACOM® Guarantee Programme (Mod-101)form in full, including all mandatory sections, within a maximum of 30 calendar days following the occurrence of the incident that led to the use of the Guarantee Programme, providing all documentation requested by ZIACOM® for assessment.
9. Have not exceeded 3 per cent per annum in replacements relative to their historical purchases. Applies only to non-osteointegrated implants.
10. You must be up to date with all your contractual obligations to Ziacom Implants SLU or any of its subsidiaries or associated companies at the time of applying for the Warranty Programme.
11. Return the ZIACOM® Products for which you wish to claim under the Guarantee Programme to ZIACOM®, duly packaged and sterilised, together with the necessary documentation to enable the guarantee to be processed and assessed. See the conditions for returning products at the end of this document.

The patient

1. Does not present any of the contraindications described in the instructions for use of the ZIACOM® Product in force at the time, at the start of, during and following treatment.
2. Has attended appointments with the Practitioner and undergone all the periodic check-ups established for the treatment on the dates designated for that purpose.
3. Must have followed the guidelines set out by the User regarding the maintenance, care and good oral hygiene of the dental implant treatment.
4. The patient must not have tampered with, in whole or in part, either themselves or through third parties, the dental implant treatment carried out.

The instructions for use, protocols and working and maintenance procedures for ZIACOM® Products are described in the leaflets and surgical and prosthodontic user manuals supplied with the ZIACOM® Products, or which can be viewed/downloaded directly from our website www.ziacom.com

Exclusions or Causes Leading to Voidance

ZIACOM® Products are excluded from the Warranty Programme if they:

1. Have not been used in accordance with the conditions of use and protocols specified by ZIACOM® as the manufacturer and/or have been used in conjunction with products from other brands or manufacturers.
2. Have been subject to any form of contamination by the User or by third parties unrelated to ZIACOM®, its network of subsidiaries or authorised distributors.
3. Have been handled and/or applied incorrectly, either in whole or in part, at any stage of the treatment, or have been handled and/or applied by unqualified personnel or by personnel without the necessary qualifications to do so in accordance with the legislation in force in each country.
4. Have reused single-use ZIACOM® products.
5. Have failed to comply with any of the points set out in section 4, General Terms and Conditions of the ZIACOM® Warranty Programme.
6. Products purchased outside our official sales channels: sales network, Ziacom customer service or the e-commerce section of our website.

Any damage caused to ZIACOM® Products resulting, in whole or in part, from trauma, accidents or any other damage caused by the patient themselves or by a third party is entirely excluded from the Warranty Programme. Ziacom Medical Group S.L. shall under no circumstances be held liable for products not purchased through official sales channels which do not comply with the legal traceability requirements set out in our standards. Should you have any queries in this regard, our Customer Service Department is available Monday to Thursday from 8.30 am to 6.00 pm and on Fridays from 8.30 am to 2.00 pm.

Incident notification and claim

To make a claim under the Product Incident Guarantee Programme, you must report the incident within a maximum of 30 calendar days of it occurring, following the procedure detailed below:

1. Submit the fully completed warranty programme claim form, including all the required information and any additional details you may provide to explain the case or circumstances.
2. Send the product for which you wish to claim under the Warranty Programme, packed in a sterilisation bag and properly sterilised, together with the form mentioned in the previous point. If the product is not sent packed in a sterilisation bag and autoclaved (see cleaning, disinfection and sterilisation instructions on the website ), the Quality Department will return it to the clinic. The ZIACOM® Customer Service department or its authorised distributor will provide you with a personalised Warranty Programme Code, sent by email together with the corresponding application form (Mod-101), which you must complete and submit in accordance with the instructions to access the Warranty Programme. You can also download this form from the website ziacom.com
3. The ZIACOM® Quality Department will not commence the investigation of any warranty claim until it has received all the fully completed documentation and the product(s) covered by the warranty. The Quality Department will request the necessary information to begin the investigation. If the form is not completed correctly, the Quality Department will return the form and the product to the clinic.
4. The ZIACOM® Quality Department will review the documentation within a maximum of 30 calendar days from receipt at ZIACOM®’s head office of all the documentation required for the investigation. Once this period has elapsed, the Quality Department will issue a written decision to the User setting out the outcome of the Warranty Programme, in which it will either accept or reject the warranty claim.
5. Should the Quality Department not receive the correctly completed form, the correctly sterilised product or the information necessary for the assessment of the case within 30 days of the initial request, the Quality Department may reject the Guarantee Programme without the customer being entitled to make a claim.