Ormco/Sybronendo: 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

Is my product affected?

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

• UPC 00889989002652
• UPC 00889989002669

Check against the official notice below — it lists the full affected range.

What happened

Ormco/Sybronendo has recalled SnapLink orthodontic brackets (reference part number 438-2190, L6R SnapLink, Slot .022) due to complaints that the lower buccal tube slide doors do not stay closed properly. The defect affects approximately 3.6 million brackets distributed across the United States, multiple U.S. territories, and numerous international countries. When the slide doors fail, the buccal tubes may break or become damaged, which could cause teeth to rotate and potentially delay orthodontic treatment.

If the defect goes unnoticed, patients may experience extended treatment lasting approximately 1 to 3 additional months, along with inconvenience to both patients and clinicians. The recall affects all lot numbers with UDI numbers 00889989002652 and 00889989002669. The source document does not specify a remedy for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: US:AK,AL,AR,AZ,CA,CO,CN,CT,DC,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA,MD,ME,MI,MN,MO,MS,MT,NC,ND,NE,NH,NJ,NM,NV,NY,OH,OK,OR,PA,RI,SC,SD,TN,TX,UT,VA,VT,WA,WI,WV,WY OUS: Argentina, Australia, Barbados, Bahamas, Bolivia, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, Hong Kong, Indonesia, Japan, Cambodia, Korea, Cayman Islands, Sri Lanka, Myanmar, Mexico, Malaysia, Netherlands, Quantity: 3,632,493 brackets Lot/code info: All Lots UDI #s: 00889989002652 & 00889989002669

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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