CLASS II Device recall · Reported 9 Apr 2014 · FDA Enforcement Report
Titanium Orthos Brackets, an orthodontic bracket recalled
Ormco/Sybronendo is recalling Titanium Orthos Brackets, an orthodontic bracket. The recall was initiated on 25 Mar 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1321-2014
- FDA event ID
- 67861
- Recalling firm
- Ormco/Sybronendo, Glendora, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Mar 2014
- FDA classified
- 2 Apr 2014
- Reported
- 9 Apr 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Dental Devices
Timeline
| 25 Mar 2014 | Recall initiated by company | |
| 2 Apr 2014 | Classified by FDA | +8 days |
| 9 Apr 2014 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Ormco Corporation inititated recall of U2R Titanium Orthos (0.22+9/+9/0), Part Number 449-6212, Lot Number 121359169, because the color ID dot was marked on the wrong tie-wing of the brackets.
Product as listed by the FDA
Titanium Orthos Brackets, an orthodontic bracket. 022 +9/+9/0, Part Number 449-6212, Lot Number 121359169. A fixed attachment on a tooth which holds an archwire during orthodontic treatment.
Where it was distributed
US and Canada.
Questions about this recall
Is Titanium Orthos Brackets, an orthodontic bracket recalled?
Yes. Ormco/Sybronendo recalled Titanium Orthos Brackets, an orthodontic bracket on 25 Mar 2014. The recall is Class II and its status is Terminated. Recall number Z-1321-2014.
Why was it recalled?
Ormco Corporation inititated recall of U2R Titanium Orthos (0.22+9/+9/0), Part Number 449-6212, Lot Number 121359169, because the color ID dot was marked on the wrong tie-wing of the brackets.
Which lots are affected?
Part Number 449-6212, Lot Number 121359169.
Where was it sold?
US and Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Ormco/Sybronendo
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Ormco Damon Q2 Orthodontic Metal Bracket recalled by Ormco/Sybronendo | Ormco/Sybronendo | Labeling Errors | Nationwide |
| Device | CLASS II | SnapLink, Ref Part No. 438-2191, L6L SnapLink, Slot .022 recalled | Ormco/Sybronendo | Device Malfunction | 51 states |
| Device | CLASS II | SnapLink, Ref Part No. 438-2190, L6R SnapLink, Slot .022 recalled | Ormco/Sybronendo | Device Malfunction | 51 states |
| Device | CLASS II | Elements Obturation Unit (EOU) used recalled by Ormco/Sybronendo | Ormco/Sybronendo | Other | Nationwide |
| Device | CLASS II | Sealapex Xpress recalled by Ormco/Sybronendo | Ormco/Sybronendo | Packaging Defects | Nationwide |
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|---|---|---|---|---|---|
| Device | CLASS II | Grandio Universal Nano-Hybrid Restorative Material recalled | Henry Schein | Packaging Defects | Nationwide |
| Device | CLASS II | GM Helix Implant, Endosseous Dental Implant Article No. recalled | Straumann USA | Packaging Defects | Nationwide |
| Device | CLASS II | KL Owen Custom Orthodontic Solution recalled by Klowen Braces | Klowen Braces | Device Malfunction | Nationwide |
| Device | CLASS II | Straumann n!ce PMMA Full-arch Restoration recalled | Straumann USA | Other | 8 states |
| Device | CLASS II | Straumann n!ce Zr, HT, Full-arch Restoration recalled | Straumann USA | Other | 8 states |