Brand Name: Transcend Product Name: Transcend Econo Kit (UB) - Singles Model/Catalog Number: 4817- Software Version:
Summary
The FDA issued a Class II for Brand Name: Transcend Product Name: Transcend Econo Kit (UB) - Singles Model/C by Ultradent Products, Inc.. Reason: Due to a manufacturing issue, red particulates present in the expressed composite..
Details
Source
Device Recall
External ID
Z-3067-2024
Action Date
2024-09-18
Status
Ongoing
Category
device
Product Description
Brand Name: Transcend Product Name: Transcend Econo Kit (UB) - Singles Model/Catalog Number: 4817- 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
Lot/Code Info: Lot Code: Model No 4817; UDI-DI 00883205033680; Lot Number C1464; Expiration Date 30-Jun-2026
Quantity Affected: 560
Reason for Recall
Due to a manufacturing issue, red particulates present in the expressed composite.
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
Type: Voluntary: Firm initiated
Recall Initiated: 2024-08-02
Company
South Jordan, UT
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 257 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Ultradent Products, Inc. has 12 FDA actions in our database, including 5 recalls and 7 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Ultradent Products, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Ultradent Products, Inc. have FDA actions?
Ultradent Products, Inc. has 12 FDA actions in our database, including 5 recalls and 7 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3067-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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