FDA Medical Device Recalls (openFDA)
Kerr Corp: Kerr TempBond Clear, Part # 33351, 1717 West Collins Avenue, Orange, CA 92867. Intended for use in a dual-cured, temporary resin-based cement designed to be used in conjunction with temporary restoration such as crowns, bridges, inlays and onlays.
- Recall number
- Z-0074-2010
- Recalling firm
- Kerr Corp
- Product
- Kerr TempBond Clear, Part # 33351, 1717 West Collins Avenue, Orange, CA 92867. Intended for use in a dual-cured, temporary resin-based cement designed to be used in conjunction with temporary restoration such as crowns, bridges, inlays and onlays.
- Status
- Terminated
- Initiated
- 2009-09-09
- Posted
- 2009-10-23
- Terminated
- 2011-12-12
- Reason
- The recall was initiated because the catalyst portion of the syringe may have polymerized, therefore making the product unusable.
- Root cause
- Nonconforming Material/Component
- Action
- Kerr Corporation issued an "Urgent Medical Device Recall" dated September 8, 2009. The letter informed customers that the product recalled was shipped to their establishment between June and July 2009 and if they have any of the affected products listed to contact Kerr Customer Care at 1-800-537-7123 to receive an RMA number. The RMA will allow for a quick return and replacement or credit.
- Quantity
- 13,518 units
- Distribution
- Worldwide Distribution -- United States, Canada, Mexico, Hong Kong, Israel, Singapore, Colombia, Dominican Republic and Europe.
- Lot, serial or model codes
- Part Number 33351, Lot Numbers: 3252902, 3229807, 3268505, 3277455, 3257280, 3258772 and 3269811.
- 510(k) numbers
- ["K982590"]
- 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