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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 90
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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