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

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  Reason
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  Affected products

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