Ormco SnapLink Brackets Recalled for Slide Door Failure
Ormco/Sybronendo is recalling SnapLink brackets because lower buccal tube slide doors may not stay closed, potentially causing tooth rotation or treatment delays.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves functional failure leading to treatment delays and inconvenience, but the source does not report hospitalizations, serious injuries, or deaths, fitting the Moderate criteria for low-risk functional issues without severe health consequences.
Plain-English summary
Ormco/Sybronendo is recalling SnapLink orthodontic brackets (Ref Part No. 438-2191) due to an increase in complaints that the lower buccal tube slide doors do not stay closed. The affected product is distributed in the United States and multiple international locations.
The recall is being taken because functional failure of the buccal tubes may cause the tooth to rotate, delay treatment, and inconvenience the patient and clinician. If the issue is not noticed, it may extend treatment by approximately 1 to 3 months.
Clinicians and patients should check their SnapLink brackets for this specific defect. The source text does not provide specific instructions for disposal or replacement, but the recall is active for the identified product.
The recalled product
- Product
- SnapLink, Ref Part No. 438-2191, L6L SnapLink, Slot .022, TQ--28, Ang +2, Rot +2, Qty 10, Made in Mexico, CE 0086, Rx Only
- Manufacturer
- Ormco/Sybronendo
- Affected units
- 3,632,493
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lots UDI #s: 00889989002652 & 00889989002669
Distribution
Part of a larger recall action
This product is one of 2 recalled by Ormco/Sybronendo under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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