Zimmer Biomet Recalls Vanguard Knee System Due to Label Mismatch
Zimmer Biomet is recalling 8 units of Vanguard Knee System femoral components because outer carton labels do not match inner sterile packaging labels.
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 without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Zimmer Biomet, Inc. is recalling 8 units of the Vanguard Knee System -PS Open Box Femoral Left, 62.5 mm (Item Number: 183126). The recall is due to a labeling discrepancy where the label on the outer carton or patient labels does not match the label on the inner sterile packaging.
The affected units are identified by Lot Number J6255863 and UDI (01)00880304270794(17)280411(10)J6265594. These units were distributed to facilities in Arkansas, Missouri, Minnesota, New Jersey, New York, Ohio, and Virginia.
Healthcare providers should stop using these specific units and contact Zimmer Biomet for further instructions. Patients who have already received these implants should consult their healthcare provider to verify the correct implant details.
The recalled product
- Product
- Vanguard Knee System -PS Open Box Femoral Left, 62.5 mm Item Number: 183126
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 8
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: J6255863 UDI: (01)00880304270794(17)280411(10)J6265594
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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