Zimmer Biomet Recalls Vanguard Knee System Due to Label Mismatch
Zimmer Biomet is recalling eight units of the Vanguard Knee System because the outer carton labels do not match the 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: This is a Class II recall involving a labeling discrepancy. The hazard is a potential for incorrect device selection or use, which is a moderate risk but does not involve a direct structural defect or reported injuries.
Plain-English summary
Zimmer Biomet, Inc. is recalling eight units of the Vanguard Knee System -PS Open Box Femoral Right, 65 mm (Item Number: 183108). The recall was initiated because the label on the outer carton or the patient labels does not match the label on the inner sterile packaging.
The affected units are identified by Lot Number J6265594 and UDI (01)00880304270893(17)280411(10)J6255863. These units were distributed to facilities in Arkansas, Missouri, Minnesota, New Jersey, New York, Ohio, and Virginia.
Healthcare providers and patients should verify that the labels on the outer carton and the inner sterile packaging match before using the device. If a mismatch is found, the device should not be used, and the facility should contact Zimmer Biomet for instructions on return or replacement.
The recalled product
- Product
- Vanguard Knee System -PS Open Box Femoral Right, 65 mm Item Number:183108
- 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: J6265594 UDI: (01)00880304270893(17)280411(10)J6255863
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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