Z-0037-2017Class II
Zenostar MT Color Impulse orange, art. no. 681168
Ivoclar Vivadent, Inc. / initiated 2016-05-27 / Terminated / root cause: manufacturing process
Ivoclar Vivadent, Inc. began a recall of Zenostar MT Color Impulse orange, art. no. 681168. Product Usage: For coloring dental porcelain on . FDA classified it as Class II and gives the reason as "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". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-0037-2017
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Ivoclar Vivadent, Inc.
- Product
- Zenostar MT Color Impulse orange, art. no. 681168. Product Usage: For coloring dental porcelain
- Product code
- EIH Powder, 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.
- Root cause tag
- manufacturing process
- FDA 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 in commerce
- 5 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.
- Product codes and lots
- 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
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0017-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0018-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0019-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0020-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0021-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0022-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0023-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0024-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0025-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0026-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0027-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0028-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0029-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0030-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0031-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0032-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0033-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0034-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0035-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0036-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0037-2017 | Class II | Terminated | Voluntary: Firm initiated |
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