FDAClass IINovember 28, 2018

Vanguard Knee System -PS Open Box Femoral Left recall

Vanguard Knee System -PS Open Box Femoral Left, 62.5 mm Item Number: 183126

Why was Vanguard Knee System -PS Open Box Femoral Left recalled?

Label on the outer carton or the patient labels does not match label on the inner sterile packaging

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: J6255863 UDI: (01)00880304270794(17)280411(10)J6265594

Product
Vanguard Knee System -PS Open Box Femoral Left, 62.5 mm Item Number: 183126
Recalling firm
Zimmer Biomet, Inc.
Quantity
8 units
Distribution
AR, MO, MN, NJ, NY, OH, MN , NJ, VA
Recall date
November 28, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls