Defective Products

FDA Reviewing Medical Device Reports for Philips CPAP Recall

FDA Reviewing Medical Device Reports for Philips CPAP Recall

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

Read More


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.

Read More


Will Exactech Joint Replacement Lawsuits be Centralized in MDL?

Will Exactech Joint Replacement Lawsuits be Centralized in MDL?

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.

Read More


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

Read More


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.

Start Your Free Case Evaluation Now

Read More


Exactech’s Defective Polyethylene Plastic Insert

Exactech’s Defective Polyethylene Plastic Insert

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. 

 Read: Exactech Knee & Ankle Replacement Recall

Read More


Philips Expands Recall, Now Includes Certain Trilogy Evo Models

Philips Expands Recall, Now Includes Certain Trilogy Evo Models

Philips Respironics has now expanded its recall of breathing devices to include certain Trilogy Evo ventilators. In summary,

  • The expanded recall covers 215 Trilogy Evo ventilators and 51 Trilogy Evo repair kits in the U.S.
  • The expansion followed the discovery that the PE-PUR foam used in devices in the original recall was also used to make some Trilogy Evo ventilators.
  • The FDA has categorized this expanded recall as a Class 1, the most serious type of recall.

Read More


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?

Read More


Are You Using a Defective CPAP Machine?

Are You Using a Defective CPAP Machine?

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?

Read More


When Did Philips Know about CPAP Toxic Foam?

When Did Philips Know about CPAP Toxic Foam?

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.

Read More


Contact Us Today for Help!