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
- Recall Number
- Z-1205-2012
- Event Number
- 61270
- Firm
- Kerr Corporation
- FEI Number
- 2024312
- Product Code
- EMA
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- March 3, 2011
- Posted
- March 14, 2012
- Terminated
- March 14, 2012
- Address
- 1717 W Collins Ave, Orange, CA, 92867-5422
Description
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.
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.
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.
Worldwide Distribution - USA (nationwide) and the countries of Canada, Philippines, Italy, Netherlands, and the UK.
627 units total (601 units in the US)