Product Wiki · Recalls · Health Canada — Medical Devices

Vanguard Total Knee System-PS Open Box Femoral Components — recall 44403

Health Canada — Medical Devices · Canada · 2017-01-25 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
44403
Date of alert
2017-01-25
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: 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%.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/vanguard-total-knee-system-ps-

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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