FDA recall Z-0906-2023

Product

DeRoyal Tonsillectomy Tray, REF 89-10698.01

Reason for recall

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.

Distribution

Distribution in US states of VA, and SC.

Key facts

Status

Terminated

Initiation date

2022-11-28

Report date

2023-01-11

Termination date

2026-03-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Powell, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0906-2023