Z-0025-2017 Class II Terminated
FDA device recall Z-0025-2017 was initiated by Ivoclar Vivadent, Inc. on May 27, 2016 and is designated Class II. 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. The recall status is terminated (terminated June 14, 2018). Affected quantity: 11 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 12, 2016
- Initiation Date
- May 27, 2016
- Termination Date
- June 14, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11 units
Product Description
Zenostar MT Color A4 60ml, art. no. 681054. Product Usage: For coloring dental porcelain
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.
Distribution Pattern
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.
Code Information
Lot No: U38746, exp date: Sep 15 2017