Brand Name: Fusio Liquid Dentin, part number N21SB, N21SC. Product Usage: The intended use of this device is as a self-e
FDA device recall Z-1115-2012 · posted 2012-02-28 · Terminated
Recall details
- Recalling firm
- Kerr Corporation
- Reason for recall
- A recall was initiated because Pentron Clinical has confirmed that the Fusio Liquid Dentin is not as flowable as ideally expected.
- Action taken
- Pentron Clinical sent a Medical Device Recall letter dated September 8, 2010 (via USPS 1st class mail) to all affected customers. The letter identified the affected product, the reason for the recall and the actions to be taken. Customers were instructed to examine their inventory for the affected product, return any remaining in stock and complete and fax back the enclosed recall return form. Customers were advised to contact Pentron Clinical Customer Service at (800) 551-0283, (option 1) directly to handle the arrangements of a quick return and replacement.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- EBF
- Quantity affected
- 382 units total (207 units in US)
- Distribution
- Worldwide Distribution - USA (nationwide) in the countries of Austria, Bulgaria, France, Great Britain, Netherlands, Japan, Lebanon, Malaysia and South Africa.
- Date initiated
- 2010-08-19
- Date posted
- 2012-02-28
- Date terminated
- 2012-02-28
- Location
- Orange, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARTISTE SE FLOWABLE COMPOSITE, MODEL N280 (K072545) | Pentron Clinical Technologies | 2007-10-26 |