The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2151-2020·Announced 2020-06-03

Biomet Vanguard Knee System Recalled for Elevated Endotoxin Levels

Biomet, Inc. is recalling 11 units of Vanguard Knee System tibial bearings due to potential endotoxin levels exceeding specification limits.

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 involves a high-risk medical device (knee prosthesis) with a potential contamination hazard (endotoxin) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Biomet, Inc. is recalling 11 units of Vanguard Knee System tibial bearings. The recall involves specific CR and CR-L Mono Lock Tibial Bearings in various sizes, including 10 MM X 71 MM, 10 MM X 83 MM, 10 MM X 79 MM, and 14 MM X 79 MM.

The reason for the recall is the potential presence of elevated endotoxin levels that exceed the specification limit. Endotoxins are substances that can cause adverse health effects if present in medical devices at high concentrations.

The affected products were distributed worldwide, including in the United States, Canada, India, Japan, Mexico, the Netherlands, Singapore, Taiwan, Thailand, and other locations. Healthcare providers and patients who have received these specific knee prostheses should contact Biomet, Inc. for further instructions.

The recalled product

Product
Knee Products: 189260 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 MM X 71 MM 189720 Vanguard Knee System, CR Mono Lock Tibial Bearing, 10 MM X 83 MM 189320 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 MM X 83 MM 189700 Vanguard Knee System, CR Mono…
Manufacturer
Biomet, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
11

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 (4)

  • Lot Numbers: UDI Number 630770 Vanguard Knee System
  • CR-L Mono Lock Tibial Bearing
  • CR Mono Lock Tibial Bearing
  • 14 MM X 79 MM (01)00880304556119(17)220115(10)505490

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 →

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