A Greatbatch Standard Offset Cup Impactor recall has been initiated due to failed sterilization testing of the reusable surgical devices. Devices that have failed such testing can potentially lead to infections and other serious health consequences, including death. Affected patients and their families may be able to file a lawsuit and seek compensation with the help of a product liability lawsuit attorney.
For more information, contact Attorney Group. We offer free, confidential, no obligation consultations. We can help answer your questions, and if you choose to pursue a case we can connect you with an affiliated Greatbatch Standard Offset Cup Impactor recall attorney who can assist you throughout the legal process.
Important: The time you have to pursue a claim is limited. Contact us for more information.
Recalled Devices May Lead to Serious Infections or Death
Greatbatch Medical initiated a recall of its Standard Offset Cup Impactor with POM-C Handle because the devices failed sterility testing when sterilized in a dedicated instrument case, which is not manufactured by Greatbatch. Standard Offset Cup Impactors are reusable medical devices used to implant cups in the hip socket during hip joint replacement surgeries and must be sterilized before surgical use. If the surgical devices are not properly sterilized, they can lead to severe health consequences, including serious infection and death.
The devices were initially recalled on July 29, 2016, and the U.S. Food and Drug Administration (FDA) issued an updated device recall notice notifying health care providers using the devices and patients undergoing procedures with the Standard Offset Cup Impactor of new sterilization recommendations. Nearly 3,000 devices have been recalled in the United States. Recalled devices were manufactured from January 2004 to December 2013 and distributed from July 30, 2004 to December 22, 20915.
Greatbatch Medical issued a press release in November 2016, which includes a complete list of affected devices and their catalog number. Customers who have questions regarding the recalled devices can contact Greatbatch Medical, and health care providers and patients may also report adverse reactions or quality problems to the FDA’s Adverse Event Reporting Program.
How a Greatbatch Standard Offset Cup Impactor Recall Lawyer Can Help
Product makers have a duty to provide safe products. If there are risks of harm associated with their products, they also must provide adequate warnings. If a product maker fails to fulfill this duty, it could be held liable in lawsuits for injuries that may result.
People injured by the fault of others may be eligible to recover money for:
- Medical Expenses
- Lost Wages
- Pain and Suffering
The families of those killed may be eligible to recover money for funeral expenses and the pain that comes with losing a loved one.
The Time You Have to Pursue a Claim is Limited. Contact Us Today.
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Please note that the law limits the time you have to pursue a claim or file a lawsuit for an injury. If you think you have a case, you should not delay taking action.