DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06
Reported: November 13, 2024 Initiated: October 3, 2024 #Z-0308-2025
Product Description
DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06
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.
Details
- Recalling Firm
- DeRoyal Industries Inc
- Units Affected
- 384 units
- Distribution
- US Nationwide distribution in the state of OH.
- Location
- Powell, TN
Frequently Asked Questions
What product was recalled? ▼
DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06. Recalled by DeRoyal Industries Inc. Units affected: 384 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 13, 2024. Severity: Moderate. Recall number: Z-0308-2025.
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