Children's Orthopedic TracePack (DeRoyal) – Smoke Evacuation Pencil Issue (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06
Brand
DeRoyal Industries Inc
Lot Codes / Batch Numbers
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
Products Sold
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
DeRoyal Industries Inc is recalling DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06 due to DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Evacuation Pencil. The recall is due to Str. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026