FDA CLASSIFIES STRYKER SHAPEMATCH RECALL CLASS I (Orthopedics This Week)
Stryker Corporation announced on April 10, 2013 that the FDA has classified the voluntary recall of the company’s ShapeMatch Cutting Guides as a Class I Recall.
A Class I Recall, according to the FDA, is a situation in which “there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”
Stryker told surgeons to discontinue using and ordering the guides last November and recalled the device in January 2013. The company said the actions were du...
