FDA Medical Device Recalls (openFDA)
Ivoclar Vivadent, Inc.: Zenostar MT Color A1 60ml, art. no. 681050, Product Usage: For coloring dental porcelain
- Recall number
- Z-0021-2017
- Recalling firm
- Ivoclar Vivadent, Inc.
- Product
- Zenostar MT Color A1 60ml, art. no. 681050, Product Usage: For coloring dental porcelain
- Status
- Terminated
- Initiated
- 2016-05-27
- Posted
- not on file
- Terminated
- 2018-06-14
- 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.
- Root cause
- Process design
- Action
- 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.
- Quantity
- 94 units
- 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, serial or model codes
- Lot No: U51483, exp date: Nov 10 2017; U43963, exp date: Nov 2 2017; U43927, exp. date: Nov 2 2017; and U38867, exp date: Sep 16 2017
- 510(k) numbers
- ["K152118"]
- PMA numbers
- not on file
- Product code
- EIH
- Firm FEI
- 1316092
- Firm city
- Amherst
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28