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Defective surgical alignment tool the cause of injury

Recent claims against Stryker Orthopaedics, for its ShapeMatch Cutting Guide, suggest that the medical manufacturing subsidiary may be guilty of negligence and providing the public with a defective surgical device. The ShapeMatch Cutting Guide was recalled in April of 2013 when reported injuries due to the product began to be discovered. 

The Stryker ShapeMatch Cutting Guides were most often used during knee surgeries to help surgeons determine the best place to make an incision. Stryker decided to self-recall the cutting guide when they were made aware of the potential harmful side effects it could cause. Safety technicians at Stryker found that a defect in the device's software failed to meet most surgeons' pre-op planning strictures that were entered into a web-based application. When surgeons attempted to manually fix the parameters in order to compensate for Stryker's mistake, it was eventually realized that these manual fixes had not been previously approved by the Food and Drug Administration and were therefore faulty.  

The negative issues that arise from Stryker's faulty surgical device include mobility limitations, multiple surgeries, joint instability, lasting pain, and other adverse health problems. One lawsuit in particular claims that shortly after the patient went through knee surgery, she began experiencing serious joint discomfort and limited mobility with pain. Upon further testing, an examination revealed that the knee replacement surgery was done incorrectly, not because the surgeon made a mistake, but because the Stryker ShapeMatch Cutting Guide misaligned the incisions.

Stryker's attempts to refute their shoddy manufacturing jobs are getting less and less respect. With other defective surgical devices in the news, such as the Stryker Rejuvenate and Stryker ABG II hip replacement systems, it is time the FDA steps in and takes a closer look at the inner-workings of Stryker and its parent-company, Howmedica Osteonics Corporation. 

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