Biomet Recalls Vanguard Knee System Bearings Due to Endotoxin Levels
Biomet, Inc. is recalling 107 units of Vanguard Knee System PS Mono Lock Tibial Bearings because they may contain elevated endotoxin levels that exceed specification limits.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a high-risk pathogen indicator (endotoxin) without reported illnesses, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Biomet, Inc. is recalling 107 units of Vanguard Knee System PS Mono Lock Tibial Bearings. The recall was initiated because the products may contain elevated endotoxin levels that exceed the established specification limits.
The affected products were distributed worldwide, including in the United States, Canada, and various international locations such as India, Japan, Mexico, and Singapore. The specific units involved are identified by various catalog numbers and UDI codes listed in the official recall documentation.
Consumers and healthcare providers who have these specific knee implant components should contact Biomet, Inc. for further instructions on how to proceed. The FDA has classified this as a Class II recall, indicating that the use of, or exposure to, the violation may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Knee Products: 189420 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 63 MM 189422 Vanguard Knee System, PS Mono Lock Tibial Bearing, 12 MM X 63 MM 189442 Vanguard Knee System, PS Mono Lock Tibial Bearing, 12 MM X 67 MM 189460 Vanguard Knee System, PS Mono Lock Tib
- Manufacturer
- Biomet, Inc.
- Hazard
- Affected units
- 107
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 (3)
- Lot Numbers: UDI Number 530900 Vanguard Knee System
- PS Mono Lock Tibial Bearing
- 10 MM X 71 MM (01)00880304451322(17)220118(10)758570
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 recalled by 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 13 products in this recall →Related recalls
Same manufacturer · Biomet, Inc.
See all →- ModerateIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Packaging Damage
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assembly Recall for Packaging Damage
FDA (Devices) · 2026-08-12
- ModerateIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assemblies Recalled Due to Potential Packaging Damage
FDA (Devices) · 2026-08-12
Same hazard · endotoxin
See all →- HighMedline Medical Convenience Kits Recalled for Endotoxin Levels
FDA (Devices) · 2026-09-02
- HighMedline Neurosponge Kits Recalled for Endotoxin Levels
FDA (Devices) · 2026-09-02
- HighMedline Neurosurgical Kits Recalled for Endotoxin Contamination
FDA (Devices) · 2026-09-02
- HighMedical Convenience Kits Recalled Over Endotoxin Variability in Neurological Sponges
FDA (Devices) · 2026-08-05
- HighRitmed Neurological Sponges Recalled Due to Potential Endotoxin Level Variability
FDA (Devices) · 2026-08-05