Recall Z-0627-2023— DeRoyal Industries Inc

Name: FDA recall Z-0627-2023
Creator: U.S. Food and Drug Administration
Published: 2022-11-03

Class II · Ongoing

Class II FDA medical device recall by DeRoyal Industries Inc, initiated 2022-11-03. FDA's recall record names no specific 510(k) clearance for this event. Product: DeRoyal KIT TOTAL HIP, REF 89-8861.07. Reason: DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled..

Recalling firm: DeRoyal Industries Inc
Classification: Class II
Status: Ongoing
Initiated: 2022-11-03
Firm location: Powell, TN, United States

Product description

DeRoyal KIT TOTAL HIP, REF 89-8861.07

Reason for recall

DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

Data sourced from openFDA. This site is unofficial and independent of the FDA.