FDA Device recall Z-0028-2017
Zenostar MT Color B3 60ml, art. no. 681057
- FDA Device
- Class II
- terminated
- Published 2016-10-12
On 2016-10-12 the FDA classified a Class II recall of Zenostar MT Color B3 60ml, art. no. 681057 by Ivoclar Vivadent, citing the primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to s….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0028-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-05-27 |
| Published | 2016-10-12 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ivoclar Vivadent |
| Distribution | US |
Product
Zenostar MT Color B3 60ml, art. no. 681057. Product Usage: For coloring dental porcelain
Reason
The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.
Identifiers
| code_info | Lot No: U38751, exp date: Sep 15 2017 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0028-2017%22
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