—#197384

Product

DeRoyal Tonsillectomy Tray, REF 89-10698.01

FDA product code: LRO — General Surgery Tray
Device class: Class 2
Medical specialty: General, Plastic Surgery
Affected lot / code info: GTIN 50749756373222, Lots: 57466936 exp 8/1/2026; Lot 57897761 exp 6/1/2026

Why it was recalled

DeRoyal is recalling certain lots of surgical procedure pack products that contain a ConMed Foot Controlled Electrosurgical Suction Coagulator. The recall is due to ConMed receiving reports that the suction ports may be occluded on the affected devices. If this occurs, the affected devices will not be able to perform the suction function during use.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

DeRoyal issued an URGENT! DEROYAL RECALL NOTICE on 11/28/2022 to the distributor by email and to the end used by overnight USPS. The notice explained the problem and requested the following actions be taken: 1) Using the attached Affected Products Listing, identify affected surgical pack numbers in your inventory and place in quarantine to prevent further use. Please return the packs that you have in inventory to us. You will be given credit or replacement for the returned product. 2) Complete the NOTICE OF RETURN FORM, indicating all affected products found in your inventory. Please return the completed form to DeRoyal via fax to 865-362-3716 or recalls@deroyal.com no later than December 15, 2022. 3) If you have questions regarding credit for the recall, please contact Jennifer Marsh at jmarsh@deroyal.com or by phone 865-362-4203 or email us at recalls@deroyal.com. 4) PLEASE COMPLETE AND RETURN THIS FORM EVEN IF YOU NO LONGER HAVE ANY INVENTORY. 5) If you have further distributed these products, it is required by federal law that your customers be notified of this recall. You may either do this directly by forwarding our recall notification and notify us that you have done so, or you may provide us with your customer list and we will contact them.

Recalling firm

Firm: DeRoyal Industries Inc
Address: 200 Debusk Ln, Powell, Tennessee 37849-4703

Distribution

Distribution pattern: Distribution in US states of VA, and SC.

Timeline

Recall initiated: 2022-11-28
Posted by FDA: 2023-01-05
Terminated: 2026-03-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #197384. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.