DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06
- Company
- Deroyal Industries Inc
- Recall Initiated
- October 3, 2024
- Posted
- November 5, 2024
- Recall Number
- Z-0308-2025
- Quantity
- 384 units
- Firm Location
- Powell, TN
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.
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
Root Cause
Under Investigation by firm
Action Taken
DeRoyal issued an URGENT! DEROYAL RECALL NOTICE to its consignees on 10/03/2024 via email. The notice explained the issue, potential risk, and requested the return of the affected packs. If the affected product was further distributed, the notice directed the distributor to notify its customers. This may be achieved directly by forwarding the recall notification and notify DeRoyal that you have done so, or the distributor may provide DeRoyal with your customer listing allowing them to contact your customers.