FDA (Devices) recall action 97021
The FDA (Devices) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.
Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired material.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
TrueDent Cyan dental resin cartridges are being recalled because a formatting error switches the day and month in the expiration date. 100 units are affected.
TrueDent Clear dental resin cartridges are being recalled because a formatting error switches the day and month in the expiration date. 78 units are affected.
TrueDent Magenta dental resin cartridges are being recalled because a formatting error switches the day and month in the expiration date. 94 units are affected.
TrueDent White dental resin cartridges are being recalled because a formatting error switches the day and month in the expiration date. 109 units are affected.
TrueDent Yellow dental resin cartridges are being recalled because a formatting error switches the day and month in the expiration date. 68 units are affected.