Ormco/Sybronendo: 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

Is my product affected?

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

• 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 438-2191) due to complaints that the lower buccal tube slide doors do not stay closed properly. The recalled product was distributed across the United States, multiple international locations, and Canada, with approximately 3.6 million brackets affected across all lot numbers.

When the slide doors fail to remain closed, the buccal tubes may break or become damaged, which can cause teeth to rotate and potentially delay orthodontic treatment by one to three months. The recall record does not specify a remedy or instructions 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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