Health product recall

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