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Health product recall

Snaplink Brackets (2014-03-27)

Starting date:
March 27, 2014
Posting date:
January 9, 2015
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-43189

Recalled Products

Snaplink Brackets

Reason

One lot of Snaplink Buccal Tube Brackets has been mislabelled. L6L Snaplink Brackets (part no. 438-2191) are incorrectly labelled as l6r Snaplink Brackets (part no. 438-2190). The L6L bracket is correctly packaged in a yellow tray, has a yellow ID dot to indicate a distal/gingival location and the hook orientation is intended for left distal placement.

Affected products

Snaplink Brackets

Lot or serial number

121361561

Model or catalog number

438-2190

Companies
Manufacturer
Ormco Corporation
1332 South Lone Hill Avenue
Glendora
91740
California
UNITED STATES