Z-2286-2020Class II

Ormco Damon Q2 Orthodontic Metal Bracket, Part No. 491-9834, L3R Hi Tq Hook, Tq +13 degrees, Rx. Manufactured...

Name: Z-2286-2020 Ormco Damon Q2 Orthodontic Metal Bracket, Part No. 491-9834, L3R Hi Tq Hook, Tq +13 degrees, Rx. Manufactured...
Creator: Ormco/Sybronendo
Published: 2020-01-14
License: https://open.fda.gov/license/

Ormco/Sybronendo / initiated 2020-01-14 / Terminated / root cause: manufacturing process

FDA source

Ormco/Sybronendo began a recall of 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... on 2020-01-14. FDA classified it as Class II and gives the reason as "The bracket torque was mislabeled on the packaging". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2286-2020
Classification: Class II
Status: Terminated
Initiated: 2020-01-14
Posted: 2020-06-05
Terminated: 2025-02-10
Recalling firm: Ormco/Sybronendo
Product: 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.
Product code: EJF Bracket, Metal, Orthodontic
Reason for recall: The bracket torque was mislabeled on the packaging.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm, Ormco, sent "URGENT: MEDICAL DEVICE CORRECTION" letters dated 1/6/2020 via USPS on 1/14/2020 to consignees explaining the brackets were mislabeled and the risk associated with using the incorrect bracket. The consignees were requested to call Ormco customer service at 1-800-854-1741 or email: [email protected] to log any complaints related to this issue; assess your patients; over-label the affected product in inventory using the enclosed corrected label and complete the enclosed acknowledgement form and email the form to [email protected] within 10 business days. If you have any questions or require additional information, please contact our customer care department at 800-854-1741, between the hours of 7am to 5pm (PST) or send an email to [email protected].
Quantity in commerce: 2,189 units
Distribution: 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.
Product codes and lots: Lot number 031902599

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2286-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2286-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-17	2020-06-05

Product code EJF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)