BEUDAMED
    FDA Enforcement Class II Ongoing

    COR Disposable Kit, 8 mm. Cartilage Transplant System.

    Recall: Z-1314-2025 · Reported March 19, 2025

    Enforcement

    Recall Number
    Z-1314-2025
    Event ID
    96347
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    DePuy Mitek, Inc., a Johnson & Johnson Co.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 19, 2025
    Initiation Date
    February 24, 2025
    Classification Date
    March 11, 2025
    Address
    249 Vanderbilt Ave, Norwood, MA, 02062-5033, United States

    Description

    COR Disposable Kit, 8 mm. Cartilage Transplant System.

    Reason

    Device is missing the pin in the graft loader component.

    Code Info

    Model No. 252109 & 252112; GTIN: 10886705012374 & 10886705012404; Lot No. 23C11, 23C12, 23E04, 23F02, 23R03, 24A02, 24B01, 24C17, 24P07, 23C13, 23D03, 23D14, 23F01, 24C15, 24K07 & 24N10.

    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.

    Quantity

    US: 131 units; OUS: 312 units