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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:
Read the FDA Notification Order
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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Exactech Recalled Polyethylene Insert due to the possibility of premature wear and degradation, expanding the initial recall of its knee and ankle replacement systems.
In August 2021, Exactech first issued a recall of its knee arthroplasty polyethylene insert packaged in non-conforming bags limiting it to only those products with a remaining shelf life of five years or greater as of August 31, 2022. However, as of February 7, 2022, that recall has been expanded to include ALL knee and ankle polyethylene inserts packaged in non-conforming bags regardless of label or shelf life.
Philips Respironics has now expanded its recall of breathing devices to include certain Trilogy Evo ventilators. In summary,
The Exactech Hip Implant Liner 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, approved for use in primary and revision hip replacement surgeries, has been reported as being prone to a high rate of early failure. Premature failure of the device puts some patients at a higher risk of complications and revision surgery.
HAVE YOU EXPERIENCED PREMATURE FAILURE OF YOUR DEVICE?
Are you still using one of the Philips defective CPAP, BiPAP or other ventilator machines? Have you experienced any serious health problems? Are you aware that the sound abatement foam can break down and lead to health problems?
After recently conducting an inspection of a Philips Respironics manufacturing facility, the US FDA released an update related to the June 2021 Class I recall of Philips Respironics CPAP, BiPaP and other ventilators.
In June, a voluntary recall by Philips Respironics, affecting millions of its devices, was issued due to potentially serious health risks related to its CPAP, BiPAP, or ventilator machines’ sound abatement foam. Since then, CPAP lawsuits have been filed by those who have suffered injuries after using the recalled devices.
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In June of this year, Philips Respironics announced a voluntary recall of several models of its CPAP, BiPAP, and other ventilator devices. With 93 proposed class-action lawsuits being filed by the end of September, a request was made to consolidate all claims before one judge for coordinated management as part of a multidistrict litigation. (MDL).
The Judicial Panel of Multidistrict Litigation (JPML) recently heard arguments concerning an MDL. The outcome? Due to the similarity of the claims, the JPML granted motions to consolidate the pretrial proceedings. As of October 8, 2021, there were more than 100 lawsuits filed against Philips.
According to Johns Hopkins, “sleep apnea happens when upper airway muscles relax during sleep and pinch off the airway, which prevents you from getting enough air. Your breathing may pause for 10 seconds or more at a time until your reflexes kick in and you start breathing again.”