CLASS II Device recall · Reported 12 Oct 2016 · FDA Enforcement Report
Zenostar MT Color A4, art recalled by Ivoclar Vivadent
Ivoclar Vivadent is recalling Zenostar MT Color A4, art, distributed nationwide in the US. The recall was initiated on 27 May 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0025-2017
- FDA event ID
- 74320
- Recalling firm
- Ivoclar Vivadent, Amherst, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 May 2016
- FDA classified
- 4 Oct 2016
- Reported
- 12 Oct 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Dental Devices
Timeline
| 27 May 2016 | Recall initiated by company | |
| 4 Oct 2016 | Classified by FDA | +130 days |
| 12 Oct 2016 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
Zenostar MT Color A4 60ml, art. no. 681054. Product Usage: For coloring dental porcelain
Where it was distributed
US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.
Nationwide AlaskaAlabamaArizonaCaliforniaColoradoConnecticutFloridaIowaIllinoisIndianaKansasLouisianaMassachusettsMarylandMichiganMinnesotaMissouriNorth CarolinaNorth DakotaNebraska
Questions about this recall
Is Zenostar MT Color A4, art recalled?
Yes. Ivoclar Vivadent recalled Zenostar MT Color A4, art on 27 May 2016. The recall is Class II and its status is Terminated. Recall number Z-0025-2017.
Why was it recalled?
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.
Which lots are affected?
Lot No: U38746, exp date: Sep 15 2017
Where was it sold?
US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Ivoclar Vivadent
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|---|---|---|---|---|---|
| Device | CLASS II | Article No. NA6050411, Valiant PhD No. 1 Econo recalled | Ivoclar Vivadent | Device Malfunction | Nationwide |
| Device | CLASS III | Heliomolar Refill . 210/A3, Product recalled by Ivoclar Vivadent | Ivoclar Vivadent | Other | NY |
| Device | CLASS III | Heliomolar Refill . 110T, Product recalled by Ivoclar Vivadent | Ivoclar Vivadent | Other | NY |
| Device | CLASS III | Heliomolar Refill . 140/A2, Product recalled by Ivoclar Vivadent | Ivoclar Vivadent | Other | NY |
| Device | CLASS III | Heliomolar Refill . 110/A1, Product recalled by Ivoclar Vivadent | Ivoclar Vivadent | Other | NY |
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| Device | CLASS II | KL Owen Custom Orthodontic Solution recalled by Klowen Braces | Klowen Braces | Device Malfunction | Nationwide |
| Device | CLASS II | Straumann n!ce PMMA Full-arch Restoration recalled | Straumann USA | Other | 8 states |
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