BEUDAMED
    FDA Enforcement Class II Terminated

    Gender Solutions" Natural-Knee¿ Flex System: N-K FLEX MBACK SZ 0 PAT N-K FLEX MBACK SZ 1 PAT N-K FLEX MBACK SZ 2 PAT

    Recall: Z-1248-2014 · Reported March 26, 2014

    Enforcement

    Recall Number
    Z-1248-2014
    Event ID
    67503
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    March 26, 2014
    Initiation Date
    February 25, 2014
    Classification Date
    March 20, 2014
    Termination Date
    March 24, 2015
    Address
    1800 W Center St, Warsaw, IN, 46580-2304, United States

    Description

    Gender Solutions" Natural-Knee¿ Flex System: N-K FLEX MBACK SZ 0 PAT N-K FLEX MBACK SZ 1 PAT N-K FLEX MBACK SZ 2 PAT

    Reason

    A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device.

    Code Info

    Item Numbers 00541800000 00541800001 00541800002

    Distribution

    Worldwide Distribution-USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, FL, IL, IN, KS, LA, ME, MI, MO, MS, NC, ND, NE, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI, and the countries of Canada, Australia, India, Austria, Japan, Czech Republic, Seoul Korea, France, Venezuela, Germany, Luxembourg, Spain, and Switzerland.

    Quantity

    3638 units