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.
What this means for you
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.
See all 2 products in this recall →Related recalls
Same manufacturer · Zimmer Biomet, Inc.
See all →- HighZimmer Biomet Recalls Spinal Rod Cutters Due to Fracture Risk
FDA (Devices) · 2020-12-30
- ModerateZimmer Biomet Recalls Polaris Spinal System Screws for Labeling Update
FDA (Devices) · 2020-12-23
- HighZimmer Biomet Recalls Hip Prosthesis Cups Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Component Due to Sterilant Concerns
FDA (Devices) · 2020-11-11
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02