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. The components are intended for use in total knee arthroplasty.
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 Tibial Bearing 12x71/75 (Item Number: 183442). The recall is due to a labeling error where the components are marked with the incorrect size. These products are intended for use in total knee arthroplasty.
The affected units are from Lot Number 388680 with an expiration date of 5/19/2022. The products were distributed worldwide, including nationwide in the United States in the states of CA, GA, KS, LA, MA, MI, MN, OH, TX, VA, WA, and WI, as well as in the Netherlands.
Healthcare providers and patients should verify the size of any implanted or pending components against the correct specifications. If a component with this specific lot number and item number is found to have incorrect sizing, it should not be used. Patients who have already had these components implanted should contact their healthcare provider for evaluation.
The recalled product
- Product
- Vanguard Complete Knee System, Vanguard CR Tibial Bearing 12x71/75, Item Number: 183442 Product Usage: For use in total knee arthroplasty
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- 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: 388680
- Exp. Date 5/19/2022
Distribution
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.
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