CLASS II Device recall · Reported 17 Jun 2020 · FDA Enforcement Report

Ormco Damon Q2 Orthodontic Metal Bracket recalled by Ormco/Sybronendo

Ormco/Sybronendo is recalling Ormco Damon Q2 Orthodontic Metal Bracket, distributed nationwide in the US. The recall was initiated on 14 Jan 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot number 031902599

Quantity recalled2,189 units

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-2286-2020
FDA event ID: 85427
Recalling firm: Ormco/Sybronendo, Glendora, CA
Classification: Class II
Status: Terminated
Recall initiated: 14 Jan 2020
FDA classified: 5 Jun 2020
Reported: 17 Jun 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Dental Devices

Timeline

14 Jan 2020	Recall initiated by company
5 Jun 2020	Classified by FDA	+143 days
17 Jun 2020	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The bracket torque was mislabeled on the packaging.

Product as listed by the FDA

Ormco Damon Q2 Orthodontic Metal Bracket, Part No. 491-9834, L3R Hi Tq Hook, Tq +13 degrees, Rx. Manufactured by Ormco Corporation, This device is intended for use for the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed.

Where it was distributed

Worldwide Distribution: US (nationwide) to states of: AR, AZ, FL, GA, IL, LA, MS, NC, NE, NJ, NY, PA, TN, and TX. Foreign distribution was made to Belgium, Czech Republic, France, Germany, Israel, Italy, Kuwait, Latvia, Lebanon, Norway, Poland, Portugal, Saudi Arabia, Slovakia, South Africa, Spain, Switzerland, Tunisia, United Arab Emirates, and United Kingdom.

Nationwide Arkansas Arizona Florida Georgia Illinois Louisiana Mississippi North Carolina Nebraska New Jersey New York Pennsylvania Tennessee Texas

Questions about this recall

Is Ormco Damon Q2 Orthodontic Metal Bracket recalled?

Yes. Ormco/Sybronendo recalled Ormco Damon Q2 Orthodontic Metal Bracket on 14 Jan 2020. The recall is Class II and its status is Terminated. Recall number Z-2286-2020.

Why was it recalled?

The bracket torque was mislabeled on the packaging.

Which lots are affected?

Lot number 031902599

Where was it sold?

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

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