FDA recall Z-1315-2025

DePuy Mitek, Inc., a Johnson & Johnson Co. · Class II · device

Product

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

Reason for recall

Device is missing the pin in the graft loader component.

Distribution

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.

Key facts

Status: Ongoing
Initiation date: 2025-02-24
Report date: 2025-03-19
Voluntary/Mandated: Voluntary: Firm initiated
Location: Norwood, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1315-2025