Z-3068-2024Class II

Brand Name: Transcend Product Name: Transcend Singles Universal Body (UB) Refill 10pk Model/Catalog Number...

Name: Z-3068-2024 Brand Name: Transcend Product Name: Transcend Singles Universal Body (UB) Refill 10pk Model/Catalog Number...
Creator: Ultradent Products, Inc.
Published: 2024-08-02
License: https://open.fda.gov/license/

Ultradent Products Inc. / initiated 2024-08-02 / Open, Classified / root cause: manufacturing process

FDA source

Ultradent Products, Inc. began a recall of Brand Name: Transcend Product Name: Transcend Singles Universal Body (UB) Refill 10pk Model/Catalog Number: 4757- Software Version: N/A Product Description... on 2024-08-02. FDA classified it as Class II and gives the reason as "Due to a manufacturing issue, red particulates present in the expressed composite". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3068-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-08-02
Posted: 2024-09-06
Recalling firm: Ultradent Products Inc.
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
Product code: EBF Material, Tooth Shade, Resin
Reason for recall: Due to a manufacturing issue, red particulates present in the expressed composite.
Root cause tag: manufacturing process
FDA root 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
Product codes and lots: Lot Code: Model No 4757; UDI-DI 00883205028334; Lot Number C15C2; Expiration Date 31-May-2026

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3068-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3066-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-06
Z-3067-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-06
Z-3068-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-06

Product code EBF

K201795Class IITranscendUltradent Product, Inc. / cleared 2020-09-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)