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
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
Damon Q2 Gingivally Offset Brackets
Lot or serial number
All lots.
Model or catalog number
- 491-8990
- 491-8991
- 491-9990
- 491-9991
Companies
- Manufacturer
-
Ormco Corporation, also trading as Sybronendo
1332 SOUTH LONE HILL AVENUE
GLENDORA
91740
California
UNITED STATES