BEUDAMED
    FDA Recall 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 · Initiated October 10, 2013

    Recall

    Recall Number
    Z-2571-2018
    Event Number
    80420
    Firm
    Cayenne Medical Inc.
    FEI Number
    3006108336
    Product Code
    HTW
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 10, 2013
    Terminated
    February 26, 2019
    Address
    16597 N 92nd St, Ste 101, Scottsdale, AZ, 85260-1847

    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.

    Action

    Customers were contacted on approximately 10/10/2013 and were instructed to return any affected products on hand.

    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