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 due to the potential that ShapeMatch Cutting Guides may not have been manufactured in accordance with surgeon preoperative planning parameters or may have been manufactured outside of the planning ranges specified in the 510(k) clearance.
The problem was identified through standard post-market surveillance of product complaints. A Product Notification was issued to surgeons and hospital risk managers which described the known hazards and harms potentially associated with the use of the affected products, which could result in a knee not functioning properly.
The guides are intended to be used as...
