Quality and Compliance

No recalls posted

For questions regarding a recall please contact our Director of Regulatory Affairs and Corporate Compliance at 1-800-243-6049 x5 or [email protected].

Quality Policy

Exsurco Medical is committed to a policy of “Quality Without Compromise.” We are committed to exceeding our customers’ expectations by developing and delivering safe and effective medical devices. Through vigilant implementation and maintenance of our quality management system, we are committed to the highest quality standards for the patients we serve. We will achieve this by:

• Complying with applicable quality, safety, and regulatory requirements
• Monitoring our customers’ total experience
• Continuously developing and improving medical devices that redefine excision science
• Conducting ourselves with integrity and striving for excellence in all we do

Please see below for the most current information for each product line:

Amalgatome MD

Amalgatome MD Split Thickness Tissue Recovery System and Sterilzation Tray User Guide X100573 Rev. K

Amalgatome MD Split Thickness Tissue Recovery System and Sterilzation Tray User Guide UK-NL-DE-AT X101802 Rev. C

Amalgatome MD Split Thickness Tissue Recovery System and Sterilzation Tray User Guide BG X101809 Rev. C

Amalgatome SK

Amalgatome SK Tissue Processing System User Guide X100894 Rev. F

Amalgatome SK Tissue Processing System User Guide UK-DE-NT-AT X100894-EU1 Rev. C

Amalgatome SK Tissue Processing System User Guide BG X100894-EU2 Rev. C

Amalgatome SD

Amalgatome SD System & Sterilization Tray User Guide X101456 Rev. G

Mesh|Ex

Mesh|EX System & Sterilization Tray User Guide X101880 Rev. A

Warranty

• Exsurco reusable devices (the Amalgatome SD,  Amalgatome® MD and Amalgatome® SK) carry a one-year warranty from date of purchase.  Should your device require any type of repair or service during this period,  it is covered under the warranty.  Please contact our customer service to set up a return through our return authorization process.  Per the operator's manual it is noted that in order for repair to be covered under warranty, the device must NOT have been altered in any manner or repaired by anyone other than our Exsurco Technical Service Department.  Exsurco reserves the right to bill for repairs under the warranty period if it is determined that the customer has abused the device.
• The one-year warranty covers all parts and repair service during this period (both for complaints and non-complaints) for our reusable devices.
• Our sterile disposable items are one-time use and do not carry a warranty.  If for some reason a customer is not satisfied with the product, please call or email customer service above to request a credit or replacement item.
• If during the warranty period your device must be returned, Exsurco may provide a loaner device to use while the return is being evaluated and/or repaired.  This is all part of the Exsurco Return Policy and will be explained by our customer service department when issuing the Return Authorization.

Service & Repair

Exsurco Medical is here to serve you and assist you with any questions that may arise while using our products.  Exsurco guarantees you will be satisfied with our product.  If for some reason you are not satisfied with our product (both the single sterile and reusable) please refer to the below information for help in requesting service for your product:

• Should one of our products require service please contact customer service at [email protected] or 1-800-243-6049 x4.  Our customer service team will issue you a return authorization number in order to process your return.
• Exsurco Medical has a fully staffed, expert technical service and repair department on site.  We do NOT send any product out to a third party for repair.  Our skilled repair technicians will coordinate and perform all the device repairs.
• We cannot accept products back to our facility without a return authorization for business tracking purposes.
• All of our reusable devices that require sterilization for use must be clean and sterilized prior to being returned.  A proof of sterilization is required on all returned devices.
• All devices must be shipped in a safe and protected manner to prevent damage.  If there is concern regarding the return shipping carton please contact our customer service team.  You may be required to purchase a return shipping transportation case for our reusable products.

Corporate Compliance and Code of Ethics

Exsurco Medical, Inc. is committed to upholding the highest standards of ethics, integrity, and accountability in pursuit of our mission and purpose. To achieve this, we must strive for excellence in all of our behaviors and everything we do. Our commitment to these standards are the core values of our company.  We understand that the laws and regulations in the health care industry are complex and Exsurco’s Code of Ethical and Business Conduct has been developed to assist you in better understanding your responsibility and how Exsurco Medical expects each of us to conduct business. It is expected that you will use this document and the philosophies outlined as you conduct your daily tasks and work towards making Exsurco Medical, Inc. a best-in-class medical device company.

Purpose of our Corporate Compliance Program

• Exsurco is dedicated to being compliant to our Corporate Compliance Program while driving to meet our Vision and Objectives. Exsurco will conduct business ethically, with integrity and in compliance with all applicable federal, state, and local laws and regulations. In particular, Exsurco is particularly mindful of its obligations with respect to anti-fraud, false claims, and anti-kickback statutes. We can achieve adherence by creating a working environment where: there are ethical and proper ways to do business, commitment to our customers, encourage reporting of violations, provide processes with constant monitoring and auditing, and provide processes which help prevent, detect, or deter non-compliant behavior.
• It is the responsibility of leadership and employees of Exsurco Medical to follow the Code of Ethical and Business Conduct
• Reporting and Seeking Compliance Assistance: Exsurco expects all employees, vendors, and other business partners to report any non-compliance that is observed. Reporting can be done anonymously as there is a strict policy against any retaliation against anyone or business for good faith reporting.

• Compliance Hotline/ Email: [email protected]

Certificates of Conformance

Please see the table at the bottom of the page for Certificates of Conformance

FDA Medical Device Registration

Our products are available for use both in tissue banks for CADEVERIC USE ONLY, and for Healthcare Professionals for patient use in surgical environment. Please follow the device labeling for proper use.

View FDA Medical Device Registration

Exsurco ISO 13485 Certification