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Since April 2021, the FDA has received more than 69,000 medical device reports (MDRs), including 168 reports of death, associated with the PE-PUR foam breakdown or suspected foam breakdown, which led to the Philips CPAP recall.
Source: FDA Safety Communication
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.
June 14, 2022, a motion was filed to consolidate all Exactech joint replacement lawsuits involving recalled polyethylene inserts in hips, knees, and ankles into a federal multidistrict litigation (MDL) in the Eastern District of New York. If the motion is granted, all future Exactech recall lawsuits filed in federal court would be centralized under the MDL.
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:
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.
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 (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.
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.