OrthoFX FXTetraRecalls & reported problems
Orthofx · Updated UDI submission for Zendura material aligners. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00860003321706), received between Jul 27, 2023 and Jul 27, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Sharp Edges” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Sharp Edges1
Patient problems
- Wound Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 27, 2023Sharp Edges; Sharp Edges
THE PATIENT REPORTED HAVING A PREVIOUS SET OF ALIGNERS WITH SHARP EDGES THAT CAUSED AN INFECTION AND RECEIVED ANTIBIOTICS DUE TO THE INFECTION. A MANAGER WITHIN THE SMYLIO CUSTOMER SUCCESS TEAM MANAGER, "M", CONTACTED THE PATIENT ON (B)(6), 2023 TO REQUEST ADDITIONAL INFORMATION REGARDING THE INFECTION THEY EXPERIENCED AND WHETHER OR NOT THEY RECEIVED MEDICAL INTERVENTION. ON (B)(6), 2023, CUSTOMER SUCCESS TEAM MEMBER K POSTED ON THE SALESFORCE COMPLAINT RECORD THAT PATIENT A COMMUNICATED THAT THEIR MEDICAL DOCTOR PRESCRIBED AMOXICILLIN 875 MG ON (B)(6), 2023 FOR THE REPORTED INFECTION. THUS, ON (B)(6), THIS COMPLAINT WAS DEEMED REPORTABLE BECAUSE THE PATIENT NOTIFIED THE CS TEAM THAT SHE RECEIVED MEDICAL INTERVENTION. FOLLOWING THE REPORT OF THE INFECTION, THE CUSTOMER SUCCESS TEAM CONTINUED TO STAY IN CONTACT WITH THE PATIENT. THE PATIENT WAS NO LONGER EXPERIENCING ISSUES WITH THE INFECTION. THE PATIENT CONTACTED THE CS TEAM ON (B)(6), STATING THAT THEY RECEIVED THEIR REPLACEMENT ALIGNERS AT THEIR DOCTOR'S OFFICE AND THE DOCTOR ASSISTED WITH MAKING A FEW MODIFICATIONS, SUCH AS FILING THE ALIGNERS DOWN. THE PATIENT CONFIRMED THAT THE NEW ALIGNERS WERE NOT CAUSING ANY ADDITIONAL IS
Patient problems: Wound Infection
MAUDE report 17408624 ↗
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- Invisalign System - Comprehensive 9000Align Technology, Inc. · Aligner, Sequential239 reports
- SureSmile® 1000Orametrix, Inc. · Aligner, Sequential134 reports
- REFINEMENT CORRECTION KIT 100-0012Access Dental Lab, LLC · Aligner, Sequential120 reports
- Candid Aligner FA-0001Candid Care CO. · Aligner, Sequential54 reports
- 3M™ Clarity™ 359-8353m Unitek Corporation · Aligner, sequential1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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