FDA-Device2025-03-19Class II
COR Disposable Kit, 8 mm. Cartilage Transplant System.
DePuy Mitek, Inc., a Johnson & Johnson Co.
Hazard
Device is missing the pin in the graft loader component.
Sold states
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.
Affected count
US: 131 units; OUS: 312 units
Manufactured in
249 Vanderbilt Ave, Norwood, MA, United States
Products
COR Disposable Kit, 8 mm. Cartilage Transplant System.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1314-2025Don't want to check this manually?
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