medical Class II Updated 2024-11-13

DeRoyal Industries Inc recalls DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06

Recalled Product

DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 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
View official government recall

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