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.
FDA Recall Z-1205-2012 · Posted 2012-03-14
Recalling FirmKerr Corporation
Recall StatusTerminated
Product CodeEMA
Date Initiated2011-03-03
Date Terminated2012-03-14
Product Quantity627 units total (601 units in the US)
Reason for Recall
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.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution - USA (nationwide) and the countries of Canada, Philippines, Italy, Netherlands, and the UK.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.