Medical device manufacturer, Pentron Clinical issued a medical device safety alert concerning Correct Plus Bite Superfast. The affected part numbers are Q34IA and Q34IC.
According to the manufacturer, the current Directions for Use (DFU) for Correct Plus Bite Superfast lists a Working Time that is not indicative of the actual performance of the product. The current DFU lists the Total Working Time as 25 seconds, while the material actually provides a minimum working time of 15 seconds as outlined in the chart below:
The manufacturer explained that there are no safety or efficacy concerns associated with Correct Plus Bite Superfast.
For details, please refer to the attachment. If you are in possession of the affected products, please contact your supplier for necessary actions.