FDAClass IIMarch 21, 2018

Vanguard CR Porous Femoral 62.5mm recall

Vanguard CR Porous Femoral 62.5mm (Left Femur) For use in total knee arthroplasty

Why was Vanguard CR Porous Femoral 62.5mm recalled?

The affected products are labeled as a 62.5mm LEFT Femur; however, the contents are a Vanguard 70mm RIGHT Femur.

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?

Item #183066/Lot 132900; UDI-(01) 0088030427068 (17) 270816 (10) 132900

Product
Vanguard CR Porous Femoral 62.5mm (Left Femur) For use in total knee arthroplasty
Recalling firm
Zimmer Biomet, Inc.
Quantity
8
Distribution
US Distribution to states of: FL, WI, MD, MO, and MI.
Recall date
March 21, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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