Vanguard Knee System Series-A Standard Patella sizes 34mm Item Number: 184766
FDA Recall #Z-0938-2019 — Class II — December 21, 2018
Product Description
Vanguard Knee System Series-A Standard Patella sizes 34mm Item Number: 184766
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
90 units
Distribution
MN, VA Foreign: Korea, New Zealand and Japan
Code Information
Lot Number: 381800 UDI Number: (01)00880304434349(17)230301(10)381800 Lot NUmber: 400030 (01)00880304434349(17)230329(10)400030
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated