Device product
Zenostar MT Color Impulse orange, art. no. 681168. Product Usage: For coloring dental porcelain
Z-0037-2017
Product summary
- Event
- Event 74320
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5 units
- Official record key
device-enforcement:Z-0037-2017
Official wording
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.
Code information: Lot No: U44402, expiration date: Oct 19 2017; V01767, expiration date: Jan 18 2018; U52968, expiration date: Jan 18 2018; U53010, expiration date: Nov 16 2017; and U38982, expiration date: Sep 17 2017
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.
Derived failure modes
-
Unknown
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.