Ormco/Sybronendo Recalls SnapLink Brackets Due to Slide Door Failure
Ormco/Sybronendo is recalling SnapLink brackets because the lower buccal tube slide doors may not stay closed, potentially causing tooth rotation and 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, but the source text describes the hazard as causing inconvenience, potential tooth rotation, and treatment delays rather than serious injury or death, fitting the Moderate criteria for low-risk functional issues.
Plain-English summary
Ormco/Sybronendo is recalling SnapLink brackets (Ref Part No. 438-2190) due to an increase in complaints that the lower buccal tube slide doors do not stay closed. The affected product is a medical device used in orthodontic treatment, manufactured in Mexico and distributed across the United States and numerous international locations.
The recall is being taken because the slide doors may fail to remain closed, which can lead to broken or damaged buccal tubes. This functional failure may cause the tooth to rotate, potentially delay treatment, and inconvenience both the patient and the clinician. If the issue is not noticed, it may extend the overall treatment time by approximately one to three months.
No specific lot numbers are listed in the source text, but the recall includes UDI numbers 00889989002652 and 00889989002669. Clinicians and patients should check their inventory or current appliances for this specific product reference number and contact the manufacturer or their orthodontist for guidance on replacement or further action.
The recalled product
- Product
- SnapLink, Ref Part No. 438-2190, L6R 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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