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Recall Observatory FDA recall evidence

Device product

DeRoyal Tonsillectomy Tray, REF 89-10698.01

Z-0906-2023

November 28, 2022

Class II

Product summary

Firm
DeRoyal Industries Inc
Event
Event 91287
Status
Terminated
Classification
Class II
Quantity
320 units
Official record key
device-enforcement:Z-0906-2023

Official wording

Reason: 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.

Code information: GTIN 50749756373222, Lots: 57466936 exp 8/1/2026; Lot 57897761 exp 6/1/2026

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.