By Brad Perriello
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.
Signal Medical also put additional sizes of the device on the market and changed the shell and liner without clearing the changes with the FDA, according to the letter.
