Vanguard Knee System Series-A Standard Patella sizes 31mm Item Number: 184764
FDA Recall #Z-0937-2019 — Class II — December 21, 2018
Product Description
Vanguard Knee System Series-A Standard Patella sizes 31mm Item Number: 184764
Reason for Recall
Vanguard Knee System Series-A Standard Patella a potential commingle that could result in the size of the implant not matching the size on the label.
Recalling Firm
Zimmer Biomet, Inc. — Warsaw, IN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
45 units
Distribution
MN, VA Foreign: Korea, New Zealand and Japan
Code Information
Lot Number: 399960 UDI Number: (01)00880304431317(17)230302(10)399960
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated