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.
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 2/5 (Moderate).
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
Related recalls
Same manufacturer · Orthosensor, Inc.
See all →- HighOrthoSensor VERASENSE Sensors Recalled Due to Post-Surgical Fluid Presence
FDA (Devices) · 2018-10-17
- SevereOrthoSensor VERASENSE Sensors Recalled Due to Post-Surgical Fluid Presence
FDA (Devices) · 2018-10-17
- HighOrthoSensor VERASENSE Sensors Recalled Due to Fluid Inside Posterior Lateral Corner
FDA (Devices) · 2018-10-17
- HighOrthoSensor VERASENSE Sensors Recalled Due to Post-Surgical Fluid Presence
FDA (Devices) · 2018-10-17
- HighOrthoSensor VERASENSE Sensors Recalled Due to Fluid Inside Posterior Corner
FDA (Devices) · 2018-10-17
Same hazard · device malfunction
See all →- SevereMedtronic MiniMed Flex Insulin Pumps Recalled for Failed Verification Tests
FDA (Devices) · 2026-10-14
- ModerateWilson-Cook Recalls Hemospray Endoscopic Hemostat Due to Adherence Issues
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys CS2 Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Et Control Software Recalled for Anesthetic Delivery Interruption
FDA (Devices) · 2026-09-23
Similar recalls
- SevereOrthoSensor VERASENSE Sensors Recalled Due to Post-Surgical Fluid Presence
FDA (Devices) · 2018-10-17
- HighOrthoSensor VERASENSE Sensors Recalled Due to Fluid Inside Posterior Lateral Corner
FDA (Devices) · 2018-10-17
- SevereIntegra Cadence Total Ankle System Recalled Due to Tibial Fractures
FDA (Devices) · 2017-02-22
- ModerateOrthosensor Recalls Knee Trial Software Due to Signal Interference
FDA (Devices) · 2012-10-31
- HighFDA Recalls 84 Zimmer CAS SmartTools Knee System Instruments
FDA (Devices) · 2017-04-26
- HighOrthoPediatrics Recalls Response Spine Pedicle Screws Due to Manufacturing Defect
FDA (Devices) · 2016-01-20