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Clark Love & Hutson

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The Nationally Recognized Plaintiffs Litigation Law Firm

FDA issues warning regarding Exactech joint replacement device recall

On Behalf of | Apr 3, 2023 | Defective Medical Device Litigation |

Many Texas residents rely on medical devices and other products for survival. When these products do not work the way they should, they can cause severe injury or illness, or even death. Medical product manufacturers, distributors and sellers of medical products may be liable for any injuries caused by a defective product.

Generally, if a product is determined to be defective, and, therefore, unsafe for consumers, the company will issue a recall of the product to prevent further injury. The manufacturer or distributor may issue the recall for its own product, or the U.S. Food and Drug Administration (FDA) or other governmental agency may require the recall.

FDA warns of Exactech recall

From 2004 to 2021, Exactech joint replacement devices intended for hips, knees and ankles were recalled by the FDA due to defective packaging. The vacuum bags used to package the devices apparently were missing an oxygen barrier that would have protected the devices from oxidation.

Without this protective layer, oxidation of the polyethylene component may occur, which would result in degradation of the plastic component of the device. This can result in quicker device failure or component fractures that could lead to revision surgeries or bone loss. Some patients with advanced cases of osteolysis or bone degeneration may even become permanently disabled.

In March of 2023, The FDA issued a warning to health care providers and patients, stating that they should carefully monitor Exactech devices for wear or failure. The warning also included a list of signs to look for that would indicate that a replacement device was failing.

Generally, patients who are not experiencing pain or other signs of device failure will not need to have their devices removed. However, for patients who are noticing signs of device failure, action must be taken.

People who suffer injuries due to medical product recalls may be entitled to compensation. An attorney specializing in medical products liability may be able to help you file your claim against the company that manufactured or distributed a defective product.