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Transcend recallZ-3068-2024 · Ultradent Products, Inc. · initiated Aug 2, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Ultradent Products, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Due to a manufacturing issue, red particulates present in the expressed composite.

FDA root cause category: Material/Component Contamination

What the company is doing

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

Recall details

Recall number
Z-3068-2024
Status
Open, Classified
Initiated by the company
Aug 2, 2024
Posted by the FDA
Sep 6, 2024
Recalling firm
Ultradent Products, Inc.
Quantity
2450
Product code
EBF
FDA submissions
K201795
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

Product description

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 (models, lots, serial numbers)

Lot Code: Model No 4757; UDI-DI 00883205028334; Lot Number C15C2; Expiration Date 31-May-2026

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

1 device cleared under K201795 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 95175).

Sources and updates

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