SnapLink, Ref Part No. 438-2191, L6L SnapLink, Slot .022, TQ--28, Ang +2, Rot +2, Qty 10, Made in...

FDA Device Recall #Z-1258-2020 — Class II — January 17, 2020

Recall Summary

Recall Number Z-1258-2020
Classification Class II — Moderate risk
Date Initiated January 17, 2020
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Ormco/Sybronendo
Location Glendora, CA
Product Type Devices
Quantity 3,632,493 brackets

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

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 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

Lot / Code Information

All Lots UDI #s: 00889989002652 & 00889989002669

Other Recalls from Ormco/Sybronendo

Recall # Classification Product Date
Z-1257-2020 Class II SnapLink, Ref Part No. 438-2190, L6R SnapLink, ... Jan 17, 2020
Z-2286-2020 Class II Ormco Damon Q2 Orthodontic Metal Bracket, Part ... Jan 14, 2020
Z-0413-2018 Class II Elements Obturation Unit (EOU) used with respec... Dec 27, 2017
Z-2836-2016 Class II Sealapex Xpress, Part No. 33639 The brand na... Aug 31, 2016
Z-1083-2016 Class II TF Adaptive Gutta Percha Point Size SM3 50pk, P... Feb 8, 2016

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.