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NDI DISPOSABLE REFLECTIVE MARKER SPHERE (2015-05-21)
- Starting date:
- May 21, 2015
- Posting date:
- June 26, 2015
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Identification number:
- RA-53924
Recalled Product
A.NDI DISPOSABLE REFLECTIVE MARKER SPHERE
Reason
As a result of a complaint from one customer, Northern Digital Inc. (NDI) of Waterloo, Ontario has become aware of a problem in the manufacturing of one lot of disposable Reflective Marker Spheres (model/catalogue number:41773, lot C102061501), a class I device. The problem, inadequate curing of adhesive, may cause the two halves of the spheres to separate. There have been no patient injuries reported in connection with this malfunction.
Affected products
A.NDI DISPOSABLE REFLECTIVE MARKER SPHER
Lot or serial number
C102061501
Model or catalog number
41773
Companies
- Manufacturer
-
Northern Digital Inc
103 Randall Drive
Waterloo
N2V1C5
Ontario
CANADA