BEUDAMED
    FDA Enforcement Class II Terminated

    Drill (Fluted-Hard Bone), for Quattro Link 2.9mm, labeled as: a. Quattro Spade Drill, for 2.9mm, Model Number CM-9300; b. Quattro Drill 2.4mm, Hard Bone, Model Number CM-9324

    Recall: Z-2571-2018 · Reported August 8, 2018

    Enforcement

    Recall Number
    Z-2571-2018
    Event ID
    80420
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cayenne Medical Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 8, 2018
    Initiation Date
    October 10, 2013
    Classification Date
    July 28, 2018
    Termination Date
    February 26, 2019
    Address
    16597 N 92nd St Ste 101, N/A, Scottsdale, AZ, 85260-1847, United States

    Description

    Drill (Fluted-Hard Bone), for Quattro Link 2.9mm, labeled as: a. Quattro Spade Drill, for 2.9mm, Model Number CM-9300; b. Quattro Drill 2.4mm, Hard Bone, Model Number CM-9324

    Reason

    A review of complaints identified a trend for drills breaking.

    Code Info

    a. Model Number CM-9300, Lot Number 2211211, 4271209, LNR, 7181408, 1221502, 4071521, 5091602, 7221613, 8301608, 9271623, 9271619, 9271621, 59068, 59069; b. Model Number CM-9324, Lot Number LNR, LRN, 11071203, 11281201, 4031303, 6061310, 9061302, 10081305, 1061401, 7181406, 9161409, 1221503, 1221501, 4071522, 6241501, 11051503, 3011650, 5091601, 7111613, 8301609, 9271618, 9271620, 11463, 11141

    Distribution

    US distribution to AK, AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI.

    Quantity

    229 devies total