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NDI DISPOSABLE REFLECTIVE MARKER SPHERE (2015-07-27)
- Starting date:
- July 27, 2015
- Posting date:
- August 11, 2015
- 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-54584
Affected Products
A. NDI DISPOSABLE REFLECTIVE MARKER SPHERE
Reason
On April 30, 2015, NDI received a complaint from a customer reporting that a DRMS sphere fell apart while the patient's leg was being aligned with the navigation system during a total knee replacement surgery. Based on the reported complaint; NDI promptly instituted a stop ship order, and then performed a recall of the affected lot. Further investigation has identified a similar failure mode, with different root causes that have occurred at a significantly lower rate in additional lots of the product.
Affected products
A. NDI DISPOSABLE REFLECTIVE MARKER SPHERE
Lot or serial number
- C100641501
- C100641502
- C101021501
- C101791401
- C102581402
- C102811402
- C103091402
- C106861402
Model or catalog number
- 41773
Companies
- Manufacturer
-
Northern Digital Inc
103 Randall Drive
Waterloo
N2V1C5
Ontario
CANADA