The Recall Desk
ModerateFDA (Devices)·Z-0674-2018·Announced 2018-02-28

Zimmer Biomet Recalls Vanguard Knee Implant Components Due to Labeling Error

Zimmer Biomet is recalling 24 Vanguard Complete Knee System tibial bearings because they are labeled with the incorrect size.

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, and the hazard is a labeling error (incorrect size) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Zimmer Biomet, Inc. is recalling 24 units of the Vanguard Complete Knee System, specifically the Vanguard CR Lipped Tibial Bearing 10x71/75 (Item Number: 183540). These components are used in total knee arthroplasty procedures.

The recall was initiated because the knee implant components are labeled with the incorrect size. The affected units are identified by Lot Number 473290 and have an expiration date of 5/19/2022.

The products were distributed worldwide, including in the United States (California, Georgia, Kansas, Louisiana, Massachusetts, Michigan, Minnesota, Ohio, Texas, Virginia, Washington, and Wisconsin) and the Netherlands. Healthcare providers and patients should contact Zimmer Biomet for further instructions regarding the return or replacement of these components.

The recalled product

Product
Vanguard Complete Knee System, Vanguard CR Lipped Tibial Bearing 10x71/75, Item Number: 183540 Product Usage: For use in total knee arthroplasty
Affected units
24

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot Number: 473290
  • Exp. Date 5/19/2022

Distribution

Distributed nationwide across the United States.

The notice also names 12 states specifically:

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 →