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Open, Classified

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

FDA Recall Z-0308-2025 · Posted 2024-11-05

Recalling FirmDeRoyal Industries Inc
Recall StatusOpen, Classified
Product CodeLRO
Date Initiated2024-10-03
Product Quantity384 units

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.

Firm Action

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.

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide distribution in the state of OH.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K842648GENERAL SURGERY TRAYDeroyal Industries, Inc. · 1984-09-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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