FDA Alerts on Defective Packaging in Exactech Equinoxe Shoulder Systems

The U.S. Food and Drug Administration (FDA) is cautioning healthcare professionals against implanting Exactech Equinoxe shoulder systems manufactured before August 2021 due to defective packaging concerns that may elevate the risk of early issues with the shoulder replacements.

The FDA issued a safety communication on January 16, highlighting that these shoulder systems were shipped in packaging with defects that could potentially expose the components to oxygen, leading to oxidation before the shoulder replacement is implanted in patients. Such complications may necessitate additional surgery or revision surgery to address the failing implant.

Federal regulators are drawing parallels between the recent issues with Exactech Equinoxe shoulder systems and the broader manufacturing problems that prompted a significant recall of Exactech knee, hip, and ankle implants in 2022. Despite this, Exactech has chosen not to initiate a recall for the potentially defective shoulder replacements.

In February 2022, Exactech faced a recall of more than 140,000 knee replacement systems, impacting Optetrak, Optetrak Logic, and Truliant knee replacements, along with 1,500 components used in Exactech Vantage ankle replacements. Similar packaging problems affected Exactech Novation and Acumatch hip implants, leading to a recall in June 2021. The hip recall was expanded in August 2022, encompassing an additional 40,000 joint replacements at risk of premature failure.

The repercussions of these issues have manifested in over 1,500 lawsuits filed against Exactech, each claiming that patients experienced complications when the components degraded and failed due to oxygen exposure before implantation.

Legal Assistance

If you or a loved one has the Equinoxe Shoulder System implanted, Wagstaff & Cartmell is here to help.  Our experienced product liability lawyers can evaluate your case and guide you through your rights.  Time limits may affect the filing of your case so you must act promptly.

Contact us via email at mcutler@wcllp.com or call our office at (816) 701-1100 to discuss your case. Wagstaff & Cartmell is dedicated to seeking justice for those affected by these recalled products. Let us assist you in understanding your legal options and pursuing the compensation you deserve.

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