The Recall Desk
ModerateFDA (Devices)·Z-0938-2019·Announced 2019-03-06

Zimmer Biomet Recalls Vanguard Knee Patella Implants Due to Labeling Mismatch

Zimmer Biomet is recalling 90 Vanguard Knee System patella implants because a potential commingle could result in the implant size not matching the label.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard is a labeling mismatch (commingle) which is a significant quality issue but does not explicitly report injuries or hospitalizations, fitting the Moderate criteria for labeling errors.

Plain-English summary

Zimmer Biomet, Inc. is recalling 90 units of the Vanguard Knee System Series-A Standard Patella, size 34mm (Item Number: 184766). The recall is due to a potential commingle that could result in the size of the implant not matching the size on the label.

The affected units are associated with Lot Numbers 381800 and 400030. These products were distributed to Minnesota and Virginia, as well as to foreign locations in Korea, New Zealand, and Japan.

Consumers and healthcare providers should contact Zimmer Biomet for further instructions regarding the return or replacement of these specific implant units.

The recalled product

Product
Vanguard Knee System Series-A Standard Patella sizes 34mm Item Number: 184766
Affected units
90

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 2 recalled by Zimmer Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →