Scope
Ziacom Implants SLU, hereinafter “ZIACOM®”, guarantees the quality of the materials, manufacturing and proper functioning of its original ZIACOM® branded products, hereinafter the “ZIACOM® Product(s)”. The ZIACOM® Guarantee Programme, hereinafter the “Guarantee Programme”, is applicable to ZIACOM® Products. If a product is faulty, before or after its use, due to a failure in the resistance of the material and/or stability of the ZIACOM® Product during the period covered by the Guarantee Programme indicated in Section 3, notify this to ZIACOM® immediately following the Incident Notification procedure set out in Section 6 of this Guarantee Programme.
This Guarantee Programme refers exclusively to the ZIACOM® Products indicated in Section 3 and to the clinical or medical professional responsible for the treatment, hereinafter the “User”. The processing of any incident regarding a ZIACOM® Product must be managed solely and exclusively through this Guarantee Programme.
By purchasing any ZIACOM® Product and participating in this Guarantee Programme, the User accepts the terms and conditions set forth herein.
Beneficiaries
This Guarantee Programme is exclusively for the User and does not result in any type of liability vis-a-vis third parties, particularly patients or providers of any kind, who are not included in this guarantee. The coverage provided by the Guarantee Programme ONLY contemplates the substitution or replacement of the ZIACOM® Products for the same products included in the guarantee claim or for other equivalent products if the original ones are discontinued. Therefore, this Guarantee Programme does not cover any associated cost that may arise for other reasons.
Products covered
The Guarantee Programme covers the following products for the time described in the table below. The guarantee in this Programme does not exclude guarantees that the User may have as a consequence of their individual agreements with ZIACOM®.
| Implants | Lifetime guarantee. Replacement for an implant of the same type or equivalent 1 |
| Prosthetic components | 15-year guarantee. Replacement for a prosthetic component of the same type or equivalent 2 |
Important
Consumable components or products, reused single-use products and those that have a retention function are excluded from this Guarantee Programme.
- If this product has been discontinued or is no longer available on the market, it will be replaced by the product that has succeeded it or another equivalent within the ZIACOM® implants range.
- If this product has been discontinued or is no longer available on the market, it will be replaced by the product that has succeeded it or another equivalent within the ZIACOM® Prosthetic components range.
General terms and conditions
ZIACOM® will replace the faulty product(s) covered by this Guarantee Programme for another identical or equivalent product that has succeeded it if it has now been discontinued.
The guarantee periods described above will begin from the moment that the ZIACOM® Products are sold to the User. As a result, the start date of the Guarantee Programme for these products will be that appearing on the User’s sale invoice.
The Guarantee Programme will be valid so long as all the conditions of the Programme described below are fulfilled and reliably documented:
That the user
- Has directly purchased the ZIACOM® Product and this product has been purchased through an official ZIACOM® sales channel.
- Has selected the right model and type of implant for the surgical technique used and the planned treatment with implants.
- Has perfectly documented the patient’s consent.
- Has exclusively used ZIACOM® Products throughout the treatment and under no circumstance have these been modified or combined with elements or components from other manufacturers.
- Has performed and documented all regular check-ups established for the treatment and on the scheduled dates, verifying that the patient has good oral hygiene.
- Has consulted and complied with all protocols, work procedures, usage instructions for the ZIACOM® Products used during the treatment, both surgical and prosthodontic, and that were in force at the time of performing the treatment.
- Has properly selected and applied the appropriate and clinically accepted dental techniques for performing treatments with dental implant before, during and after treatment.
- Has reported and completed all mandatory parts of the ZIACOM® Guarantee Programme (Form-101) form within a maximum period of 30 calendar days after the occurrence of the incident that led to the use of the Guarantee Programme, providing all documentation requested by ZIACOM® for its investigation.
- Has not exceeded the annual 3% replacement rate for their past purchases. Only in the case of non-osseointegrated implants.
- Is up to date with all their contractual obligations with Ziacom Medical SL or any of its subsidiaries or associates at the time of requesting the Guarantee Programme.
- Has sent back to ZIACOM® the ZIACOM® Products that they want to return under the Guarantee Programme, duly packaged and sterilised, together with the documentation required to be able to process and study the guarantee. See conditions for returning products at the end of the document.
That the patient
- Does not have any of the contraindications described in the usage instructions for the ZIACOM® Product in force at the beginning, during and after the treatment.
- Has visited the User and performed all the regular check-ups established for the treatment and on the dates designated for this purpose.
- Has followed the control guidelines described by the User regarding the maintenance, care and good oral hygiene of the treatment with dental implants.
- That the patient has not manipulated, in whole or in part, by themselves or through third parties, the dental implant treatment performed.
The usage instructions, protocols and work and maintenance procedures for the ZIACOM® Products are described in the surgical and prosthodontic brochures and user manuals that accompany the ZIACOM® Products, or that can be consulted/downloaded directly from our website www.ziacom.com
Exclusion or Grounds for invalidation
Excluded from the Guarantee Programme are ZIACOM® Products that:
- Have not been used in accordance with the conditions of use and protocols specified by ZIACOM® as manufacturer and/or have been used in conjunction with products from other brands or manufacturers.
- Have undergone any type of contamination by the User or third parties unrelated to ZIACOM®, its network of subsidiaries or authorised official distributors.
- Have been handled and/or applied incorrectly, in whole or in part, in any phases of the treatment or have been handled and/or applied by staff members who are not qualified or do not have the qualifications needed to do this according to the legislation in force in each country.
- Have reused single-use ZIACOM® Products.
- Have not complied with any of the points listed in Section 4 on general conditions of the ZIACOM® Guarantee Programme.
Any damage caused to ZIACOM® Products as a result of or arising from, in whole or in part, trauma, accidents or any other damage caused by the patient themselves or by a third party, is completely excluded from the Guarantee Programme.
Notification of incidents and request
To request the guarantee under the Guarantee Programme due to an incident with a product, you must report this within a maximum of 30 calendar days after it occurs, following the procedure detailed below:
- Send the guarantee programme application form fully completed with all required information and any extra information you can provide to explain the case or circumstances.
- Send the product you wish to have replaced under the Guarantee Programme packaged in a sterilisation bag and properly sterilised; together with the form mentioned in the previous point. If the product is not sent packaged in a sterilisation bag and sterilised in an autoclave (see the cleaning, disinfection and sterilisation instructions on the website), the Quality Department will return it to the clinic. The Customer Service Department at ZIACOM® or its authorised official distributor will provide you with a personalised Guarantee Programme Code, sent by e-mail, together with the corresponding application form (Form-101) that must be completed and sent according to the instructions for accessing the Guarantee Programme. This form can also be downloaded from the website ziacom.com
- The ZIACOM® Quality Department will not start studying any incident under guarantee until it has received all documentation, perfectly completed, and the product(s) covered by this guarantee. The Quality Department will request the information required to start the investigation. In the event that the form is not completed correctly, the Quality Department will return the form and the product to the clinic.
- The analysis of the documentation by the Quality Department at ZIACOM® will take place within a maximum period of 30 calendar days from all documentation required for the study arriving at the ZIACOM® regional headquarters. After that time, the Quality Department will issue a decision in writing to the User with the resolution of the Guarantee Programme, in which it will accept or reject the request for this guarantee.
- In the event that the Quality Department does not receive the form correctly completed, the product correctly sterilised and the information required to study the case within a period of 30 days from the initial request, the Quality Department may reject the Guarantee Programme, making it impossible for the customer to make a claim.