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Vanguard Total Knee System-PS Open Box Femoral Components
- Starting date:
- January 6, 2017
- Posting date:
- January 25, 2017
- 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-61956
Reason
Zimmer Biomet is conducting a lot specific medical device field action for Vanguard Knee System PS Open Box Femoral components due to inadequate line clearance at the supplier between April 5, 2016 and September 1, 2016. As a result, the packaging of some femoral components was incorrectly labeled as either smaller or larger and/or as the incorrect side (right/left). It is highly detectable at the point of use that the device was incorrectly labelled. The estimated rate of occurrence is 0.001%.
Affected products
Vanguard Total Knee System-PS Open Box Femoral Components
Lot or serial number
More than 100 numbers, contact manufacturer
Model or catalog number
- 183102
- 183104
- 183106
- 183108
- 183110
- 183112
- 183113
- 183122
- 183124
- 183126
- 183128
- 183130
- 183132
- 183133
Companies
- Manufacturer
-
Biomet Orthopedics
56 East Bell Drive
Warsaw
46581
Indiana
UNITED STATES