Medical device manufacturer, Sybron Dental Specialties, Inc., has issued a customer notification concerning all production lots within shelf life of TempSpan CMT. The affected part numbers are N69CA and N69CS.
The manufacturer is conducting a voluntary recall of TempSpan CMT production lots that were shipped to customers since January 2011 because they may exhibit work time fluctuations and work faster than what the DFU advises. Although there are no safety or efficacy issues associated with this product according to the manufacturer, product recall is ongoing.
According to the manufacturer, the affected products were distributed in Hong Kong.
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 23 January 2013