BEUDAMED
    FDA Enforcement Class II Terminated

    AperFix AM Femoral Implant, Model numbers CM-2409 (9mm x 24 mm) and CM-2410 (10 mm x 24 mm). For orthopedic use in ligament reconstruction.

    Recall: Z-2422-2018 · Reported July 18, 2018

    Enforcement

    Recall Number
    Z-2422-2018
    Event ID
    80282
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cayenne Medical Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 18, 2018
    Initiation Date
    July 11, 2013
    Classification Date
    July 10, 2018
    Termination Date
    September 14, 2018
    Address
    16597 N 92nd St Ste 101, Scottsdale, AZ, 85260-1847, United States

    Description

    AperFix AM Femoral Implant, Model numbers CM-2409 (9mm x 24 mm) and CM-2410 (10 mm x 24 mm). For orthopedic use in ligament reconstruction.

    Reason

    Potential for AperFix 24 mm implant breaking inside the drilled femoral socket.

    Code Info

    Item Number (Lot Number): CM-2409 (40731-2, 40743-5, 41049-1, 41237-2, 41536-2, 41737-2, 42219-2), CM-2410 (40731-3, 40743-6, 41049-2, 41237-3, 41536-3, 41737-3, 42219-3).

    Distribution

    US nationwide distribution.

    Quantity

    976 units