Zimmer Biomet Recalls Vanguard 360 Knee Augments Due to Missing Bolt
Zimmer Biomet is recalling 16 Vanguard 360 Revision Knee System tibial block augments because the sterile packages contained one bolt instead of the required two.
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. The hazard is a missing component (bolt) in the sterile package, which is a packaging/labeling issue rather than a direct contamination or structural defect of the implant itself, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is recalling 16 units of the Vanguard 360 Revision Knee System 75x 5mm Universal Tibial Block Augment, Model Number 185224. The recall is due to a packaging error where the sterile packages contained only one bolt instead of the required two. These devices are intended for use in Total Knee Arthroplasty.
The affected units are from Lot 585070. The distribution pattern includes the United States (specifically Arizona, Kansas, New Mexico, Nevada, and Utah) as well as Australia and the Netherlands.
Healthcare providers and patients should contact Zimmer Biomet for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- Vanguard 360 Revision Knee System 75x 5mm Universal Tibial Block Augment, Model Number 185224 Intended for use in Total Knee Arthroplasty
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 16
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 (2)
- Lot 585070
- UDI (01) 0088030448157 (17) 230215 (10) 585070
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 · packaging error
See all →- ModerateTerumo Glidesheath Slender A-Kit Recalled for Incorrect Guidewire Packaging
FDA (Devices) · 2026-08-19
- LowRio II Nasal Pillows Interface Packaging and Labeling Discrepancy Recall
FDA (Devices) · 2026-07-22
- ModerateEMPOWR 3D KNEE insertion instruments recalled for incorrect product size packaging
FDA (Devices) · 2026-07-15
- ModerateArtegraft vascular graft recalled over incorrect lot outer packaging labeling
FDA (Devices) · 2026-03-25
- ModerateBD syringe batch may contain Luer Slip instead of Luer Lok
FDA (Devices) · 2026-03-18