Recall Z-1034-2023— MEDLINE INDUSTRIES, LP - Northfield

Name: FDA recall Z-1034-2023
Creator: U.S. Food and Drug Administration
Published: 2022-11-17

Class II · Ongoing

Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2022-11-17. FDA's recall record names no specific 510(k) clearance for this event. Product: Non-sterile procedural trays labeled as THEDA CLARK TOTAL KNEE CDS, 1 per case. Reason: Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging..

Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Classification: Class II
Status: Ongoing
Initiated: 2022-11-17
Firm location: Northfield, IL, United States

Product description

Non-sterile procedural trays labeled as THEDA CLARK TOTAL KNEE CDS, 1 per case

Reason for recall

Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging.

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