FDA Medical Device Recalls (openFDA)
Kerr Corporation: Brand Name: TempSpan CMT Temporary Cement, a temporary cement. Part Number: N69CA. The intended use of this device is to affix a temporary dental devices such as crowns or bridges to a tooth.
- Recall number
- Z-1205-2012
- Recalling firm
- Kerr Corporation
- Product
- Brand Name: TempSpan CMT Temporary Cement, a temporary cement. Part Number: N69CA. The intended use of this device is to affix a temporary dental devices such as crowns or bridges to a tooth.
- Status
- Terminated
- Initiated
- 2011-03-03
- Posted
- 2012-03-14
- Terminated
- 2012-03-14
- Reason
- The recall was initiated because Pentron Clinical has confirmed that the TempSpan Temporary Cement may have black plastic material on the surface of the paste, and it may set faster than specified.
- Root cause
- Nonconforming Material/Component
- Action
- Pentron Clinical sent an Urgent Medical Device Recall letter dated April 20, 2011, to all affected customers. The letter provided the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to complete and fax back the enclosed recall form to 1-877-677-8844 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. For questions regarding this recall call 714-516-7400.
- Quantity
- 627 units total (601 units in the US)
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of Canada, Philippines, Italy, Netherlands, and the UK.
- Lot, serial or model codes
- Lot Number: 3748413
- 510(k) numbers
- not on file
- 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