Exactech has received a warning letter from the Food and Drug Administration (FDA) concerning packaging issues with its implants that could lead to faster degradation. This warning, issued on January 19, came shortly after healthcare providers were cautioned by the FDA against implanting Exactech’s Equinoxe Shoulder Systems due to defects in their packaging. The FDA’s concern stemmed from the potential for these defects to result in patients requiring revision surgery to address problems with the affected devices. The issuance of a warning letter is a serious regulatory action, signaling violations that could lead to further enforcement measures if left unaddressed.
The root of the problem lay in the packaging of Exactech’s implants, which lacked one of the barrier layers necessary for protecting the devices from oxidation. This oversight posed a risk of accelerated degradation of the implants over time, potentially compromising patient outcomes. Despite the FDA’s alert and urging, Exactech chose not to initiate a voluntary recall of the Equinoxe Shoulder System implants affected by the packaging issue. These implants, produced between 2004 and 2021, were the focus of the FDA’s scrutiny, prompting an inspection of Exactech’s headquarters in Gainesville, Florida, in September 2023.
During this inspection, it was found that Exactech had failed to take appropriate corrective actions regarding its packaging processes. Specifically, the company had not evaluated all available data to determine the necessity of a correction and removal action. Exactech’s analysis of complaints related to its implants was incomplete, focusing solely on polyethylene wear while neglecting other important indicators of implant degradation such as instability, pain, and joint dislocation. Exactech’s delayed submission of adverse event reports, sometimes months after becoming aware of issues, raised concerns about the company’s compliance with regulatory reporting requirements. Exactech responded to the warning letter by outlining corrective actions it planned to undertake, including a review of complaints, revisions to complaint coding procedures, and staff training initiatives. The FDA deemed the adequacy of Exactech’s response undetermined at the time, as specific details regarding the outcomes of these corrective actions were not provided. This lack of transparency regarding the effectiveness of the proposed measures leaves room for continued uncertainty regarding the safety and reliability of Exactech’s implants.
The warning letter also highlighted broader compliance issues within Exactech’s operations, including deficiencies in its corrective and preventive action procedures and shortcomings in its design validation processes. These systemic deficiencies jeopardize the safety of Exactech’s products and raise questions about the company’s overall commitment to regulatory compliance. Failure to address these issues promptly could lead to further regulatory action, potentially including seizure, injunction, or civil penalties.
Exactech’s receipt of a warning letter from the FDA outlines the importance of adhering to regulatory standards in the medical device industry. The identified packaging issues with its implants, along with broader compliance deficiencies, highlight the need for quality control measures and proactive regulatory oversight to ensure patient safety and product efficacy. As Exactech works to address the concerns raised by the FDA, stakeholders must remain vigilant in monitoring the company’s progress and holding it accountable for maintaining the highest standards of quality and compliance in its operations.