Breeze Self-Adhesive Resin Cement, Part Number: N97A, Product Usage: The intended use of this device is for cementation of porcelain, resin, and metalbased inlays, onlays, crowns, bridges and posts. The material is not recommended for use on veneer restorations.
Recall
- Recall Number
- Z-0186-2012
- Event Number
- 60242
- Firm
- Kerr/pentron Dba Kerr Corporation And Pentron Clinical
- FEI Number
- 2024312
- Product Code
- EMA
- Status
- Terminated
- Root Cause
- Pending
- Initiated
- July 8, 2011
- Posted
- November 14, 2011
- Terminated
- June 28, 2013
- Address
- 1717 W. Collins Ave, Orange, CA, 92867
Description
Breeze Self-Adhesive Resin Cement, Part Number: N97A, Product Usage: The intended use of this device is for cementation of porcelain, resin, and metalbased inlays, onlays, crowns, bridges and posts. The material is not recommended for use on veneer restorations.
Pentron is voluntarily recalling the Breeze Self Adhesive Resin Cement because it was discovered that there may be a curing problem that may cause cemented crowns to fall off after use of the product.
Pentron Clinical sent an "Urgent: Medical Device Recall" letter dated July 18, 2011 with an attached Recall Return Form (via USPS First Clas mail) to all affected customers. The letter identified the affected product, explanation of the problem, and actions to be taken. Customers were instructed to discontinue use and return any affected product in their inventory. The letter asks that each customer complete and return the enclosed Recall Return Form via fax to 714-288-4609, in order to confirm receipt of the customer notification. Customers were instructed to contact Pentron Clinical Customer service at (800) 551-0283 (option 1) directly to handle the arrangements of a quick return and replacement.
Worldwide Distribution - USA (nationwide) and the countries of: Austria, Belgium, Canada, Cypress, Greece, Germany, Italy, Jordon, Poland, Romania, Turkey and Vietnam.
336 units