The FDA slapped Signal Medical with a warning letter for marketing a hip implant system that had never been approved.
During a July 31 to Aug. 11, 2014, inspection of the firm’s Marysville, Mich., facility, the investigators from the Detroit district office found that MicroSeal Total Hip Acetabular System was adulterated because Signal didn’t have an active PMA or other marketing clearance on some system components.
Specifically, the hip system includes a hood feature integrated with two separate liner models that were never cleared. In addition, the company sells two other liner sizes beyond the three available when the product was cleared for marketing.
The products are misbranded because Signal changed the device shell and liner without getting FDA approval, the warning letter says. The company responded to the Form 483, but did not address the issue of misbranding, the FDA says.
Signal Medical did not respond to a request for comment by press time.