Class 2 Device Recall Transcend

• Date Initiated by Firm: August 02, 2024
• Date Posted: September 06, 2024
• Recall Status: Open, Classified
• Recall Number: Z-3068-2024
• Recall Event ID: 95175
• 510(K)Number: K201795
• Product Classification: Material, tooth shade, resin - Product Code EBF
• Product: Brand Name: Transcend Product Name: Transcend Singles Universal Body (UB) Refill 10pk Model/Catalog Number: 4757- Software Version: N/A Product Description: Transcend universal composite is a light-cured, tooth shade resin composite material (Bis-GMA-based) to be used for direct and indirect posterior and anterior tooth restorations. Transcend universal composite is radiopaque and available in a range of dentin, enamel, and body shades. It is 79% filled by weight and 60-61% filled by volume and has an average particle size of 0.9 m (by weight) with narrow upper limit particle distribution. Component: N/A
• Code Information: Lot Code: Model No 4757; UDI-DI 00883205028334; Lot Number C15C2; Expiration Date 31-May-2026
• Recalling Firm/ Manufacturer: Ultradent Products, Inc.; 505 W 10200 S; South Jordan UT 84095-3800
• For Additional Information Contact: Emma Gillespie; 1-801-5534127
• Manufacturer Reason for Recall: Due to a manufacturing issue, red particulates present in the expressed composite.
• FDA Determined Cause: Material/Component Contamination
• Action: On 08/6/2024, the firm sent an "URGENT: MEDICAL DEVICE CORRECTION" Letter via 3-day delivery to customer informing them that firm has identified a potential presence of red or blue polyvinyl particulate in the composite. Customer are instructed to: -Discard all remaining Transcend Singles or Vit-lescence Singles from lots listed in the Recall Letter. -Fill out Customer Response Form and return to Ultradent indicating disposal of product. -For any concerns or questions related to your replacement product or product use, contact Ultradent Customer Service at 1-888-230-1420. -Should you experience any adverse reactions or quality problems with the use of this product, these can also be reported to the FDA s MedWatch Adverse Event Reporting program with online, by regular mail or by fax. o Complete and submit the report online o Regular mail or fax: download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
• Quantity in Commerce: 2450
• Distribution: US: AZ, CA,CO,FL,GA,HI, IA, ID,IL,IN,KS,KY,LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, SC, TN, TX, UT, VA, VT, WI, WV Foreign: NL, DE, CH, CZ, FR, ES
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = EBF