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Devices
Device Recall ORTHOSENSOR KNEE BALANCER, VERASENSE KNEE SYSTEM
Model / Serial
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, 411654012, 411585011, 411654014, 411654005, 411654001, 411585003.
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
No
Distribution
US Distribution to the states of : IL, MI, NY, CA, VA and NV.
Product Description
Verasense Knee System, Model SYK-TRCR 02. Intelligent disposable tibial insert that measures dynamic loads during orthopedic knee surgery.
Manufacturer
Orthosensor, Inc.
1 Event
Recall of Device Recall ORTHOSENSOR KNEE BALANCER, VERASENSE KNEE SYSTEM
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Manufacturer
Orthosensor, Inc.
Manufacturer Address
Orthosensor, Inc., 1560 Sawgrass Corporate Pkwy, 4th Floor, Sunrise FL 33323-2858
Manufacturer Parent Company (2017)
OrthoSensor Inc.
Source
USFDA
Language
English
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