Medical device recalls Moderate risk

DePuy Mitek, Inc., a Johnson & Johnson Co. recalls COR Disposable Kit, 8 mm w/ Perpendicularity. Cartilage Transplant System.

Recall date
February 24, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1315-2025
FDA classification
Class II
Brand / firm
DePuy Mitek, Inc., a Johnson & Johnson Co.
Sold / distributed
Domestic: Nationwide Distribution; Foreign: Austria, Belgium, Brazil, Switzerland, Chile, China, Colombia, Czech Republic, Germany, Spain, Finland, France, French Guyana, Greece, Israel, India, Italy, Japan, South Korea, Luxemburg, Mexico, Netherlands, Poland, Portugal & Singapore.

Why it was recalled

Device is missing the pin in the graft loader component.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

COR Disposable Kit, 8 mm w/ Perpendicularity. Cartilage Transplant System.

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