FDA Medical Device Recalls (openFDA)
Kerr Corp: TempBond Clear Syringes (base and catalyst kit), a temporary dental cement, Part Number 28637
- Recall number
- Z-1524-06
- Recalling firm
- Kerr Corp
- Product
- TempBond Clear Syringes (base and catalyst kit), a temporary dental cement, Part Number 28637
- Status
- Terminated
- Initiated
- 2006-08-14
- Posted
- 2006-09-23
- Terminated
- 2012-08-03
- Reason
- Low Bonding performance: The affected lots of product may not activate properly, which may cause lower than expected bonding performance (due to a low level of chemical cure initiator in the lots manufactured)
- Root cause
- Other
- Action
- A total of forty-one (41) consignees were sent the recall communication via USPS 1st class mail on August 14, 2006 and thirteen (13) consignees were sent the recall communication via international fax/mail on August 16. Additionally, there will be nine (9) letters sent to consignees in Australia and two (2) letters sent to consignees in New Zealand
- Quantity
- 2,007
- Distribution
- Class II Recall - Worldwide distribution ---- including USA and countries Canada, Denmark, France, Germany, Italy, Lithuania, Luxembourg, Mexico, Poland, South Africa, Spain and United Kingdom.
- Lot, serial or model codes
- Lot numbers: 444881 and 445348.
- 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