Brand Name: Transcend Product Name: Transcend Singles Universal Body (UB) Refill 10pk Model/Catalog Number: 4757- Softwa
FDA device recall Z-3068-2024 · posted 2024-09-06 · Open, Classified
Recall details
- Recalling firm
- Ultradent Products, Inc.
- Reason for recall
- Due to a manufacturing issue, red particulates present in the expressed composite.
- Action taken
- 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
- Root cause
- Material/Component Contamination
- Status
- Open, Classified
- Product code
- EBF
- Quantity affected
- 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
- Date initiated
- 2024-08-02
- Date posted
- 2024-09-06
- Location
- South Jordan, UT
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Transcend (K201795) | Ultradent Product, Inc. | 2020-09-28 |