FDAClass IIMarch 6, 2019

Vanguard Knee System Series-A Standard Patella recall

Vanguard Knee System Series-A Standard Patella sizes 34mm Item Number: 184766

Why was Vanguard Knee System Series-A Standard Patella recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Number: 381800 UDI Number: (01)00880304434349(17)230301(10)381800 Lot NUmber: 400030 (01)00880304434349(17)230329(10)400030

Product
Vanguard Knee System Series-A Standard Patella sizes 34mm Item Number: 184766
Recalling firm
Zimmer Biomet, Inc.
Quantity
90 units
Distribution
MN, VA Foreign: Korea, New Zealand and Japan
Recall date
March 6, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls