The FDA filed a formal warning against New Jersey-based orthopedics maker Extremity Medical for failures in device surveillance and malfunction reporting.
The federal watchdog agency noted 2 instances of device malfunction "that may have caused or contributed to a death or serious injury" and which were not reported to the FDA within the 30-day window.
Extremity filed a response but it was not reviewed because it was not received within 15 days of the FDA’s initial inspection report, according to the warning letter.