By Brad Perriello
The FDA sends a warning letter to Signal Medical, flagging it for making unapproved changes to its MicroSeal hip implants.
The FDA flagged Signal Medical Corp. for selling a hip implant after making changes that weren’t approved by the federal safety watchdog.
Marysville, Mich.-based Signal Medical makes the MicroSeal total hip acetabular system. In a warning letter sent in December and posted on the FDA’s website this month, the agency said the MicroSeal device includes a hood liner that wasn’t included in the 510(k) filings for the device.