Zenostar MT Color A4 60ml, art. no. 681054. Product Usage: For coloring dental porcelain
This recall has been terminated (originally issued May 27, 2016).
- Company
- Ivoclar Vivadent, Inc.
- Recall Initiated
- May 27, 2016
- Terminated
- June 14, 2018
- Recall Number
- Z-0025-2017
- Quantity
- 11 units
- Firm Location
- Amherst, NY
- Official Source
- View on FDA website ↗
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
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.
Lot / Code Info
Lot No: U38746, exp date: Sep 15 2017
Root Cause
Process design
Action Taken
Wieland sent an Urgent Medical Device Recall Notification letters dated May 27, 2016, and Response Forms to their customers via courier service to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to Segregate any affected materials immediately. Customers were asked to complete the attached Acknowledgment form and return it to Ivoclar Vivadent, Inc. by mail, fax or email as indicated on the form. For questions contact Ivoclar Vivadent Technical Customer Service at 800-533-6825.