Zimmer Biomet Recalls Vanguard Knee System Patella Components Due to Labeling Error
Zimmer Biomet is recalling 45 Vanguard Knee System patella components because a potential commingle may cause the implant size to not match 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, and the hazard is a labeling error (size mismatch) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is recalling 45 units of the Vanguard Knee System Series-A Standard Patella, size 31mm (Item Number: 184764). 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 identified by Lot Number 399960 and UDI Number (01)00880304431317(17)230302(10)399960. These products were distributed in Minnesota and Virginia, as well as in Korea, New Zealand, and Japan.
The source text does not specify instructions for consumers or healthcare providers regarding the recall.
The recalled product
- Product
- Vanguard Knee System Series-A Standard Patella sizes 31mm Item Number: 184764
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 45
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 (1)
- Lot Number: 399960 UDI Number: (01)00880304431317(17)230302(10)399960
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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