FDA Medical Device Recalls (openFDA)
Kerr Corporation: 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.
- Recall number
- Z-1100-2012
- Recalling firm
- Kerr Corporation
- Product
- 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.
- Status
- Terminated
- Initiated
- 2010-12-02
- Posted
- 2012-02-24
- Terminated
- 2012-02-24
- Reason
- 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.
- Root cause
- Nonconforming Material/Component
- 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.
- Quantity
- 622 units total (12 units in US)
- Distribution
- Worldwide Distribution - Nationwide (USA) and the countries of Vietnam, Jordan,Turkey, and Italy.
- Lot, serial or model codes
- Lot # 200466
- 510(k) numbers
- ["K060698"]
- PMA numbers
- not on file
- Product code
- EMA
- Firm FEI
- 2024312
- Firm city
- Orange
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28