As part of our rigorous post-market surveillance program Straumann welcomes feedback about our products. In order to allow us to learn as much as possible about how our products perform under actual use, as well as to assist us in complying with our regulatory reporting responsibilities, we ask that you complete and submit the Straumann Guarantee Questionnaire.
Upon receipt, Straumann will review your feedback, assess the returned product and determine whether the product meets the defined conditions for replacement under the Straumann Guarantee. When all necessary information and the product is received, replacement product can be provided in a timely manner.
1. Guarantee beneficiary and scope
This guarantee (the “Straumann Guarantee” as defined below) from Straumann USA LLC, Andover, MA (“Straumann”) applies to the products listed below and in favor of the attending physician/dentist only (the “User”). Third parties, particularly patients or intermediate suppliers, may not derive any rights from this Straumann Guarantee. The Straumann Guarantee covers the replacement of products of the Straumann Dental Implant System SDIS and certain limited Straumann CARES products (the “Straumann Products”) as defined in Section 2. The Straumann Guarantee only covers the replacement of Straumann Products and not any associated costs, including but not limited to chair time, lab fees and any other associated treatment unless otherwise specified.
2. Straumann Products covered by the Straumann Guarantee*
|Guarantee Term||Implant||Abutment attached to an implant||Tooth- and implant-supported restoration**|
|5 Year Guarantee||
|Replacement with equivalent ceramic abutment including ceramic screw-retained bars and bridges**||Replacement with equivalent ceramic restoration***|
|10 Year Guarantee||
|Replacement with equivalent metal screw-retained barsand bridges**||Replacement with equivalent metal restoration and resin nano ceramic restoration***|
|Lifetime Guarantee||Replacement with equivalent implant and equivalent abutment, if finalized.||Replacement with equivalent metal abutment||
|Roxolid® Lifetime + Guarantee||Replacement with equivalent implant and equivalent abutment, if finalized. Additionally, for Straumann® Roxolid® Implants a treatment compensation in the amount of $1,500. if implant fractures (reported after July 31,2016).****||
* Valid as of October 1, 2016
** Excluding consumable products and retentive products such as ball anchors and Locator. (Locator is a trademark of Zest Anchor LLC)
*** Including Straumann® CARES® copings, full contour crowns and bridges. EXCLUDING all other products offered by Straumann, particularly Straumann® CARES®, inlays, onlays, veneers, partial crowns and Straumann® CARES® Guided Surgery products.
**** Excludes 3.3 mm diameter implants placed in the molar region. Abutment, abutment lot/serial number or CARES project number must be provided to confirm only Straumann original products have been used.
3. Straumann Guarantee conditions
Straumann hereby guarantees that, if any Straumann Product is defective as a result of a failure of the material strength and stability of the Straumann Product during the guarantee periods set out in Section 2, Straumann will replace the Straumann Product with the same or substantially equivalent product as set forth in Section 2. The guarantee periods above commence at the time of treatment with a Straumann Product by the User. Provided however that the following guarantee conditions are individually and collectively met and documented:
3.1 Straumann Products have been used exclusively and not in combination with any other manufacturer’s products;
3.2 Return of the Straumann Products in sterilized condition (or disinfected if delivered as such);
3.3 Compliance with and application of Straumann’s instructions (in the instructions for use, among others) valid at the time of treatment as well as recognized dental procedures, during and after the treatment;
3.4 Good oral hygiene of the patient as monitored by the User;
3.5 No guarantee case resulting from an accident, a trauma or any other damage caused by the patient or a third party;
3.6 Filing of a completed and signed guarantee questionnaire not later than 90 days after a guarantee case arises;
3.7 For customized Straumann Products the User shall provide Straumann with the design data.
3.8 Special requirements for the “Roxolid Lifetime Plus Guarantee: The complaint case must be submitted and approved for product replacement first. The Roxolid Lifetime Plus Guarantee claim must be submitted online (via eShop) with restoration details within 6 months after fracture..
4. Limits and limitations
This Straumann Guarantee is the only guarantee provided by Straumann and shall apply in addition to the warranty rights conferred under the sales agreement. The User remains free to claim rights against his supplier. STRAUMANN HEREBY DISCLAIMS ANY OTHER WARRANTIES, EXPRESS OR IMPLIED AND STRAUMANN HEREBY EXCLUDES ANY LIABILITY FOR LOST EARNINGS AND DIRECT OR INDIRECT DAMAGES AS WELL AS COLLATERAL AND CONSEQUENTIAL DAMAGES, DIRECTLY OR INDIRECTLY RELATED TO STRAUMANN PRODUCTS, SERVICES OR INFORMATION.
5. Guarantee territory
This Straumann Guarantee applies worldwide to Straumann Products sold by a Straumann affiliated company or an official distributor of Straumann.
6. Modification or termination
Straumann may modify or terminate this Straumann Guarantee at any time in whole or in part. Changes to or the termination of the Straumann Guarantee will not affect the guarantee given for Straumann Products installed prior to the date of the change or termination.
Regulatory Affairs - Complaints