Breeze Self-Adhesive Resin Cement, part number: N97F. The intended use is for cementation of porcelain, resin, and metal-based inlays, onlays, crowns, bridges, and posts.
FDA Recall Z-1100-2012 · Posted 2012-02-24
Recalling FirmKerr Corporation
Recall StatusTerminated
Product CodeEMA
Date Initiated2010-12-02
Date Terminated2012-02-24
Product Quantity622 units total (12 units in US)
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.
Firm Action
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
Distribution Pattern
Worldwide Distribution - Nationwide (USA) and the countries of Vietnam, Jordan,Turkey, and Italy.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.