Biomet Recalls Vanguard M Partial Knee System MonoBlock Tibial Trays
Biomet, Inc. is recalling 105 units of Vanguard M Partial Knee System MonoBlock Tibial Trays due to potential elevated endotoxin levels.
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 3/5 (High).
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 the hazard involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Biomet, Inc. is recalling 105 units of Vanguard M Partial Knee System MonoBlock Tibial Trays, which are knee prostheses. The recall is being conducted because of the potential presence of elevated endotoxin levels that exceed the specification limit.
The affected products were distributed worldwide, including in the United States, Canada, India, Japan, Mexico, the Netherlands, Singapore, and other international locations. The recall covers specific lot numbers and UDI numbers listed in the official FDA record.
Consumers and healthcare providers should contact Biomet, Inc. for further information regarding the recall and potential replacement or repair of the affected devices.
The recalled product
- Product
- Knee Products: US154709 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, B8 US154722 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Left Medial/Right Lateral, D5 US154725 Knees Vanguard M Partial Knee System MonoBlock Tibial…
- Manufacturer
- Biomet, Inc.
- Hazard
- Affected units
- 105
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)
- Right Medial/Left Lateral
- Left Medial/Right Lateral
- C4 (01)00880304180727(17)220119(10)455810
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.
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