FDA Medical Device Recalls (openFDA)
Talladium Inc: Luminesse ML PMMA, 98x20mm, REF: 5336-B1 - Product Usage: used as a milling blank in the fabrication of provisional crowns and bridges. All blanks are solely used by a Trained Dental Technician or on the order of a dental professional.
- Recall number
- Z-0512-2021
- Recalling firm
- Talladium Inc
- Product
- Luminesse ML PMMA, 98x20mm, REF: 5336-B1 - Product Usage: used as a milling blank in the fabrication of provisional crowns and bridges. All blanks are solely used by a Trained Dental Technician or on the order of a dental professional.
- Status
- Terminated
- Initiated
- 2020-10-09
- Posted
- not on file
- Terminated
- 2022-08-17
- Reason
- Heat-cured polymethylmethacrylate (PMMA) milling blank product used to make long-term temporary crowns and bridge restorations has incorrect label. label states Part no. 5336-B1 (98x20mm). However, the item inside the box was Part no. 4302-B1 (95x20mm). An incorrect label may result in compatibility issues when setting up the disc with milling machine fixtures due to size variation.
- Root cause
- Labeling mix-ups
- Action
- On 10/09/20, Urgent Medical Device Recall notices were mailed and/or emailed to customers. Customers were asked to do the following: 1) Check your stock and quarantine the affected stock on hand to prevent further use. 2) Using the provided customer letter and Recall Acknowledgement Form templates, communicate this recall to any of your customers who have received product included within the scope of the recall. 3) Return product, complete the enclosed Recall Acknowledgement Form, scan and email to productrecall@talladium.com Complete the attached Acknowledgement form even if you do not have any affected stock, scan and email. The following contact information was provided: 800-221-6449 and www.TALLADIUM.com
- Quantity
- 10
- Distribution
- U.S. Nationwide distribution including in the states of PA, KS, OR, FL, CA.
- Lot, serial or model codes
- Lot No. 1BKI
- 510(k) numbers
- ["K142371"]
- PMA numbers
- not on file
- Product code
- EBG
- Firm FEI
- 2023129
- Firm city
- Valencia
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28