Class 2 Device Recall CS 3600

• Date Initiated by Firm: February 15, 2021
• Create Date: March 17, 2021
• Recall Status: Terminated on January 14, 2023
• Recall Number: Z-1268-2021
• Recall Event ID: 87443
• Product Classification: System, optical impression, computer assisted design and manufacturing (cad/cam) of dental restorations - Product Code NOF
• Product: Carestream Dental CS 3600 Single Use Normal Tips, Catalog Number 5941216 - Product Usage: used to record the topographic characteristics of teeth or dental impressions in three dimensions.
• Code Information: All lot numbers
• FEI Number: 3002522649
• Recalling Firm/ Manufacturer: CARESTREAM DENTAL, LLC; 3625 Cumberland Blvd Se Ste 700; Atlanta GA 30339-6406
• For Additional Information Contact: Carestream Dental Operations; 800-800-9541
• Manufacturer Reason for Recall: The mirror may become detached and fall from the unit
• FDA Determined Cause: Device Design
• Action: The firm initiated the recall by letter on 02/2/2021. The letter explained the problem, requested the consignee cease use of the product and return all affected product.
• Quantity in Commerce: 11400 devices
• Distribution: Worldwide distribution - US Nationwide distribution in the states of WA, MD, WV, NE, SC, NJ, FL, OH, CA, OR, LA, MO, NY, MI, MA, ID, TN, GA, MN, NC, PA, AZ, OK, IN and the country of Canada.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.