Damon Q2 Gingivally Offset Brackets (2020-01-06)

Starting date:

January 6, 2020

Posting date:

September 25, 2020

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-74005

Last updated:
2020-09-25

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  Reason
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  Affected products

Affected Products

Damon Q2 Gingivally Offset Brackets

Reason

Ormco received a recent increase in complaints relating to brackets in part numbers 491-8990, 491-9990, 491-8991, and 491-9991. The brackets were not gingivally offset, though the packaging was labeled as gingivally offset. Part numbers listed above were not gingivally offset.

Affected products