The Food & Drug Administration has recently issued a Class I recall for Standard Offset Cup Impactors with POM-C Handle, a device used during hip replacement surgeries and manufactured by Greatbatch Medical. These devices, used in hip replacement operations in the United States between July 30, 2004 and December 22, 2015, were found to have non-sterile parts, which can lead to serious infection and even death. Greatbatch reported to the FDA that there were nearly 3,000 patients who had a hip replacement using one of their cup impactor devices. To view the model numbers that are listed under the FDA’s recall notice, please click here.
How to Know If You Have a Case
As anyone who has experienced a major surgery knows, you hope for the best possible outcome and to wake up better off than when you entered the operating room. If a medical product or device fails to meet basic safety standards in a surgical environment, the impact can be life threatening.