Class II
Medical Device Recall: DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06
DeRoyal Industries Inc · October 3, 2024
Reason for Recall
DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Evacuation Pencil. The recall is due to Stryker receiving reports that the pencil is activating without manual input when plugged into a power source or remains active after buttons are released.
Distribution
US Nationwide distribution in the state of OH.
States Affected
NATIONWIDE
Quantity Affected
384 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0308-2025
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.