Complaint Handling Process

WHAT IS A PRODUCT COMPLAINT?

A product complaint can encompass any product Zest Dental Solutions manufactures such as hardware, processed materials, labeling and informational literature. If the product is incorrect, has not performed as expected or in another way not met your expectations or that of your patient(s), please notify Zest Dental Solutions. The Food and Drug Administration defines a complaint as any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution. Please note: If one of our products has injured (death, serious injury or malfunction) one of your patients, Zest is obligated to notify the FDA of such an incident via the Medical Device Reporting Regulation within 30 calendar days from Zest becoming aware of an event.

HOW DO I REPORT A PRODUCT COMPLAINT?

When you have a product complaint about a Zest Dental Solutions Product, please contact Zest Dental Solutions Customer Service at (800) 262-2310.

• Customer Service will assist with product identification.
• The Zest Dental Solutions Complaint Handling team will gather further details regarding the nature of the complaint and condition of the patient/user. This will include information such as:
  • Product Code/ Part Number
  • Lot Number
  • Date of Placement
  • Date of Event
  • Date of Removal
  • Identification of the hazard or fault condition (incident)
  • Description of any additional details regarding the incident
• A Product Experience Report (PER) number will be assigned.
• Any product that has come into contact with the patient is to be sterilized.
• Product is to be packaged and returned to Zest Dental Solutions according to the instructions provided by the Complaint Handling Team.