Biomet Recalls Knee Prosthesis Components Due to Endotoxin Concerns
Biomet, Inc. is recalling 12 units of the Orthopedic Salvage System Tibial Bearing because of potential elevated endotoxin levels.
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 involves a medical device with a potential contamination hazard (endotoxin) where no specific injuries or illnesses are reported in the source text, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Biomet, Inc. is recalling 12 units of the Orthopedic Salvage System (OSS) Tibial Bearing, 20 MM Standard (Product Code 150414). This product is used as a knee prosthesis component.
The recall was initiated due to the potential presence of elevated endotoxin levels that exceed the specification limit. The affected units are identified by UDI Number 292720.
The products were distributed worldwide, including in the United States, Canada, India, Japan, Mexico, and other international locations. Healthcare providers and patients should contact Biomet, Inc. for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- Knee Products: 150414 Orthopedic Salvage System (OSS) Tibial Bearing, 20 MM Standard - Product Usage: Knee prosthesis
- Manufacturer
- Biomet, Inc.
- Hazard
- Affected units
- 12
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 Numbers: UDI Number 292720 (01)00880304006492(17)211222(10)292720
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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