CLASS II Device recall · Reported 17 Apr 2013 · FDA Enforcement Report
Bracket Buccal Tube U7L DB/UL22 Roth MT HK 0/-14/0 recalled
Ormco/Sybronendo is recalling Bracket Buccal Tube U7L DB/UL22 Roth MT HK 0/-14/0, distributed nationwide in the US. The recall was initiated on 8 Mar 2013 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-1084-2013
- FDA event ID
- 64749
- Recalling firm
- Ormco/Sybronendo, Glendora, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Mar 2013
- FDA classified
- 10 Apr 2013
- Reported
- 17 Apr 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Dental Devices
Timeline
| 8 Mar 2013 | Recall initiated by company | |
| 10 Apr 2013 | Classified by FDA | +33 days |
| 17 Apr 2013 | 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 is voluntarily recalling one (1) lot of Bracket Buccal Tubes as a result of a packaging error. More specifically, the Bracket Buccal Tubes product package correctly identifies the product as gingival (0¿) offset brackets, but actually contains distal (10¿) offset brackets. Use of the affected product may cause unintended rotation of the molars. Although reversible, a delay in
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Bracket Buccal Tube U7L DB/UL22 Roth MT HK 0/-14/0 Product Usage: Bracket Buccal Tubes are intended to hold in orthodontic wires used to move teeth during orthodontic treatment
Where it was distributed
Worldwide Distribution - USA (nationwide) including the country of EU.
Questions about this recall
Why was it recalled?
Ormco Corporation is voluntarily recalling one (1) lot of Bracket Buccal Tubes as a result of a packaging error. More specifically, the Bracket Buccal Tubes product package correctly identifies the product as gingival (0¿) offset brackets, but actually contains distal (10¿) offset brackets. Use of the affected product may cause unintended rotation of the molars. Although reversible, a delay in
Which lots are affected?
Part Number 438-0184 Lot Number 051063597
Where was it sold?
Worldwide Distribution - USA (nationwide) including the country of EU.
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 26 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 |
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| 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 | 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 |
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