Zimmer Biomet Recalls Vanguard Total Knee System Femoral Components Due to Labeling Errors
Zimmer Biomet is recalling Vanguard Total Knee System femoral components because packaging labels may incorrectly identify the size or side of the implant.
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, and the source text identifies the hazard as a labeling error that risks delaying surgery, which aligns with the rubric for moderate severity involving minor labeling errors or low-risk issues without reported injuries.
Plain-English summary
Zimmer Biomet, Inc. is recalling approximately 15,000 units of Vanguard Total Knee System femoral components. The recall involves specific item numbers ranging from 183100 to 183133, which include various sizes and sides (right and left) of the open box femoral components.
The reason for the recall is that the packaging for some of these components was incorrectly labeled. The labels may identify the component as a smaller or larger size than it actually is, or as the incorrect side (right or left). This labeling error poses a risk of delay in surgery if the incorrect component is selected or used.
The affected products were distributed nationwide in the United States and in several international markets, including Argentina, Australia, Austria, Brazil, Canada, Chile, China, Costa Rica, Ecuador, Greece, India, Italy, Japan, South Korea, Malaysia, Mexico, the Netherlands, Panama, Poland, Singapore, and Thailand. Healthcare providers and patients should verify the item numbers and lot numbers against the recall list to ensure the correct components are used for surgical procedures.
The recalled product
- Product
- Vanguard Total Knee System Vanguard Open Box Femoral Components Item Number: 183100 Description: VNGD PS OPEN INTL FEM RT 55 Item Number: 183102 Description: VNGD PS OPEN INTL FEM-RT 57.5 Item Number: 183104 Description: VNGD PS OPEN INTL FEM RT 60 Item Number: 183106…
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 15,000
Distribution
Distributed nationwide across the United States.
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