Breeze Self-Adhesive Resin Cement, part number: N97F. The intended use is for cementation of porcelain, resin, and metal
FDA device recall Z-1100-2012 · posted 2012-02-24 · Terminated
Recall details
- Recalling firm
- Kerr Corporation
- Reason for recall
- The recall was initiated because Pentron Clinical has confirmed that the Breeze Self-Adhesive Resin Cement exhibits faster than expected gel and set times. If the work time is exceeded when using this material, it could possibly result in inadequate bond strength.
- Action taken
- An "Urgent Medical Device Recall" letter was sent on 12/17/2010 via USPS 1st class mail to all their customers. The letter provides the customers with an explanation of the problem identified and the action to be taken. Customers were instructed to complete and fax back the enclosed recall return form. Customers with questions were instructed to call (800) 551-0283.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- EMA
- Quantity affected
- 622 units total (12 units in US)
- Distribution
- Worldwide Distribution - Nationwide (USA) and the countries of Vietnam, Jordan,Turkey, and Italy.
- Date initiated
- 2010-12-02
- Date posted
- 2012-02-24
- Date terminated
- 2012-02-24
- 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 |
|---|---|---|
| CEMENT-IT ALL PURPOSE, MODEL N97 (K060698) | Pentron Clinical Technologies | 2006-05-10 |