Medical Devices

Exactech Expands Hip Recall, Admits Packaging Problems

Exactech Expands Hip Recall, Admits Packaging Problems

August 11, 2022. Exactech expands hip recall, adding 40,000 more hip implants to its hip replacement recall in the U.S. The company admits to packaging problems that can cause the plastic hip liners to oxidize and wear out much sooner than expected.

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FDA Order to Philips: Improve Communications on Product Recall

FDA Order to Philips: Improve Communications on Product Recall

On March 10, 2022, the FDA issued a notification order to Philips Respironics requiring the company to notify patients and others of the company’s June 2021 product recall and the health risks posed by the foam used in the recalled products.

Products in this recall include:

  • Continuous positive airway pressure machines (CPAP)
  • Bilevel positive airway pressure (BiPAP) machines
  • Mechanical ventilators
  • Listing of Devices Recalled

Read the FDA Notification Order

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Recalled Connexion GXL Hip Liner Implant Lawsuit

Recalled Connexion GXL Hip Liner Implant Lawsuit

Exactech Lawsuit: Nash & Franciskato along with co-counsel firms Cohen & Malad, LLP, and Maglio Christopher & Toale Law Firm has filed a lawsuit against Exactech, Inc., the maker of the Connexion GXL hip liner implant used in Total Hip Arthroplasty (THA) or hip replacement surgery.

Read the Press Release: Exactech Connexion GXL Hip Liner Implant Lawsuit

Nash & Franciskato has been talking with patients throughout the country who have received the Exactech Connexion GXL implants and suffered injuries associated with excessive wear to the plastic liner insert leading to early device failure.

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Premature Failure of Exactech Connexion GXL Hip Implant Liner

Premature Failure of Exactech Connexion GXL Hip Implant Liner

The Exactech hip implant liner (the Connexion GXL) is prone to premature failure, which puts some patients at a higher risk of complications and revision surgery. Exactech’s Connexion GXL hip implant liner was approved for use in primary and revision hip replacement surgeries.

HAVE YOU EXPERIENCED PREMATURE FAILURE OF YOUR DEVICE?

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Paragard IUD Breakage: 3,200+ Reports

Paragard IUD Breakage: 3,200+ Reports

Paragard, a popular intrauterine birth control device used by thousands of women, is prone to breakage and fracturing, which can lead to serious complications. And, there is evidence that the maker, Teva Pharmaceuticals, has been aware of this issue since at least 2013.

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Medical Device Recall FAQs

Medical Device Recall FAQs

A medical device recall is when the manufacturer either removes a device or takes corrective action to address a problem with a device that is in violation of the FDA laws, such as when the device is defective and/or a risk to health.

These are some basic FAQs and resources to help you understand medical device recalls.

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FDA Orders Two to Stop Selling Pelvic Mesh, Citing Safety Concerns

FDA Orders Two to Stop Selling Pelvic Mesh, Citing Safety Concerns

Surgical mesh has been used to treat hernias since the 1950s. In the 1970s, gynecologists began using it for abdominal repair of pelvic organ prolapse (POP) and in the 1990s for the transvaginal repair of POP.

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FDA’s Hidden Reports on Medical Devices

FDA’s Hidden Reports on Medical Devices

March 8, 2019. In an article published by Kaiser Health News, we learned that some medical device manufacturers have been using a secret reporting mechanism to let the FDA know of problems with their devices.

The problem? The data is hidden so that neither the public nor doctors are aware of any problems reported.

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Implant Files: A Global Investigation of the Medical Device Industry

Implant Files: A Global Investigation of the Medical Device Industry

In 2018, the medical device industry and the FDA came under fire from:

  • The powerful Netflix documentary, The Bleeding Edge, which chronicled the pain and suffering caused by complications of medical devices with little or no testing.
  • The Implant Files, a year-long investigation by the International Consortium of Investigative Journalists focused on the medical device industry and its overseers.

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Essure Device: FDA Safety Oversight after Discontinuation of US Sales

Essure Device: FDA Safety Oversight after Discontinuation of US Sales

December 20, 2018. FDA Commissioner, Scott Gottlieb, issued a statement on the new steps the FDA will take to strengthen the long-term safety oversight of Essure.  In his statement, Gottlieb said the FDA will continue to evaluate the product’s long-term safety profile even after it has been discontinued in the US market.

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