Ormco/Sybronendo: Medical Device Recall in 2020 - (Recall #: Z-1258-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: January 17, 2020

Date Posted: February 26, 2020

Recall Number: Z-1258-2020

Event ID: 84538

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.

Status: Terminated

Product Quantity: 3,632,493 brackets

Code Information:

All Lots UDI #s: 00889989002652 & 00889989002669

Distribution Pattern:

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, Nepal, Panama, Philippines, Paraguay, Russian Federation, Singapore, Thailand, Taiwan, Uruguay, Viet Nam, South Africa

Voluntary or Mandated:

Voluntary: Firm initiated