FDA (Devices) recall action 84538
The FDA (Devices) publishes a recall like this one as 2 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 2 pages.
The action is being taken due to an increase in complaints relating to the lower buccal tube slide doors not staying close. In the event of functional failure, broken/damage buccal tubes it may cause the tooth to rotate, possibly delay treatment and inconvenience the patient and clinician. If not noticed it may extend treatment by approximately 1 -3 months.
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.
Ormco/Sybronendo is recalling SnapLink brackets because lower buccal tube slide doors may not stay closed, potentially causing tooth rotation or treatment delays.
Ormco/Sybronendo is recalling SnapLink brackets because the lower buccal tube slide doors may not stay closed, potentially causing tooth rotation and treatment delays.