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Greatbatch Medical recalls Standard Offset Cup Impactor with POM-C handle for hip replacement
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Greatbatch Medical announced the recall of its Standard Offset Cup Impactor with a POM-C handle. The announcement has been labeled as a class 1 recall by the FDA.
Used during hip joint replacement surgeries to implant cups in the acetabulum, the Standard Offset Cup Impactor with a POM-C handle is provided as non-sterile and must be sterilized prior to use in surgery, according to a press release. However, the release noted the device failed sterility testing when sterilized in a dedicated instrument case. Non-sterile devices can lead to infections and other serious adverse health consequences, including death. The release noted both health care providers using this device during hip replacement surgeries and all patient groups undergoing hip replacement procedures involving the Standard Offset Cup Impactor may be affected.
Greatbatch Medical has recently developed new sterilization recommendations that meet acceptable sterility assurance levels, according to the FDA recall, which includes the device being individually wrapped during sterilization processing.
References:
investor.greatbatch.com/phoenix.zhtml?c=122233&p=irol-newsArticle&ID=2222863www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm533735.htm