Device product
DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06
Z-0308-2025
Product summary
- Event
- Event 95509
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 384 units
- Official record key
device-enforcement:Z-0308-2025
Official wording
Reason: 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.
Code information: UDI/ DI 00749756917292 (each), 50749756917297 (case): Lot Numbers: lot 58828011 exp 11/1/2024; lot 59098364 exp 1/1/2026; lot 59259658 exp 7/1/2025; lot 59839687 exp 11/1/2025
Distribution pattern: US Nationwide distribution in the state of OH.
Derived failure modes
-
Unknown
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.