FDA Device

Verasense Knee System, Model SYK-TRCR 02. Intelligent disposable tibial insert that measures dynamic loads during orthopedic knee surgery.

Hazard

Presence of one inoperable (dead) sensor pad.

What You Should Do

Remedy

OrthoSensor sent an Recall letter dated December 4, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Required Action for Users " Remove the above-referenced serial numbers from your VERASENSE inventory and quarantine. " Complete the enclosed Customer Response Form. Actions to be taken by OrthoSensor " You will be credited for these devices for your full purchase amount. The Returned Materials Authorization (RMA) number for each device in your possession is listed above. " OrthoSensor will replenish these devices as soon as they are available. For further questions please call (954) 577-7770.

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Products

Verasense Knee System, Model SYK-TRCR 02. Intelligent disposable tibial insert that measures dynamic loads during orthopedic knee surgery.
Brand
Orthosensor, Inc.
UPC
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.

Units Affected

22 devices

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