Medical device manufacturer, Ormco Corporation, has issued a medical device safety alert concerning its TF Adaptive Gutta Percha Point Size SM3-50pk. [Part number: 815-1541; Lot number: GE15011637].
The manufacturer has become aware of a mismatch of the above product's inner and outer labels. The outer package of the product is identified as SM3, which matches the product inside. However, the inner generic label is identified as ML3.
According to the manufacturer, this product would be used correctly in a properly obturated canal. If a doctor removed the cover of the tray and is only looking at the inner label, he could mistakenly use the SM Gutta Percha with a ML file system. This SM3 GP will not properly fill the canal due to smaller size and can result in the Gutta Percha slipping past the apex of the root.
Product recall is on-going.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 18 February 2016