Orthosensor Recalls Verasense Knee System Due to Inoperable Sensor Pad
Orthosensor, Inc. is recalling 22 Verasense Knee System devices because one sensor pad is inoperable. The devices were distributed to six U.S. states.
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, but the specific defect is an inoperable sensor pad with no reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Orthosensor, Inc. is recalling 22 units of the Verasense Knee System, Model SYK-TRCR 02. This intelligent disposable tibial insert is designed to measure dynamic loads during orthopedic knee surgery. The recall is due to the presence of one inoperable (dead) sensor pad.
The affected devices were distributed in the United States to the states of Illinois, Michigan, New York, California, Virginia, and Nevada. The specific lot number is 091914V11770, and the recall covers 24 specific serial numbers.
Healthcare providers and patients should stop using the affected devices and contact Orthosensor, Inc. for further instructions on replacement or return.
The recalled product
- Product
- Verasense Knee System, Model SYK-TRCR 02. Intelligent disposable tibial insert that measures dynamic loads during orthopedic knee surgery.
- Manufacturer
- Orthosensor, Inc.
- Hazard
- Affected units
- 22
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 (20)
- Model SYK-TRCR 02
- Lot # 091914V11770
- Serial #s: 411654008
- 411585023
- 411654007
- 411585032
- 411585014
- 411654016
- 411585017
- 411654015
- 411585030
- 411654020
- 411654004
- 411654010
- 411585007
- 411585005
- 411654011
- 411585036
- 411585035
- 411654018
Distribution
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