The Menaflex knee device and the company that makes it, ReGen Biologics Inc. (RGBO), is once again under the scrutiny of the Food & Drug Administration (FDA). An FDA panel has concluded that the medical device company has not offered the government agency enough data to verify that their device is safe for use. The FDA worries that the device may suffer from mechanical failures.

In addition to concerns that the knee device has not been properly studied in trials, the FDA is concerned that the medical device company has been suggesting uses for the device that are not approved, such as to repair a shoulder.

In response to the FDA’s queries regarding the safety of the medical device, ReGen questioned the fairness of the FDA’s medical device approval system. RenGen has released a statement putting forth that its medical device Manaflex is safe and effective.