BEUDAMED
    FDA Enforcement Class II Terminated

    Zimmer¿ Air Dermatome II Handpiece w/o Hose, item number 00-8851-001-01. The Zimmer Air Dermatome II handpiece and width plates are packaged inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then placed into a corrugated shipper carton or padded envelope. The Zimmer Air Dermatome II is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities.

    Recall: Z-2335-2016 · Reported August 10, 2016

    Enforcement

    Recall Number
    Z-2335-2016
    Event ID
    74636
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Surgical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 10, 2016
    Initiation Date
    July 4, 2016
    Classification Date
    August 4, 2016
    Termination Date
    June 21, 2017
    Address
    200 W Ohio Ave, Dover, OH, 44622-9642, United States

    Description

    Zimmer¿ Air Dermatome II Handpiece w/o Hose, item number 00-8851-001-01. The Zimmer Air Dermatome II handpiece and width plates are packaged inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then placed into a corrugated shipper carton or padded envelope. The Zimmer Air Dermatome II is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities.

    Reason

    The surface coating applied to the device is blistering, peeling and discoloring after usage over time

    Code Info

    Lot # 61987607, Serial # 500041  500060 Lot # 61989397, Serial # 500061  500080 Lot # 62007988, Serial # 500111  500130 Lot # 62008620, Serial # 500131  500150 Lot # 62244213, Serial # 500311  500330 Lot # 62267555, Serial # 500392  500411 Lot # 62289845, Serial # 500432  500451 Lot # 62309684, Serial # 500492  500511 Lot # 62374706, Serial # 500572  500591 Lot # 62393940, Serial # 500612  500631 Lot # 62415890, Serial # 500672  500691

    Distribution

    US Nationwide Distribution including states of: AL, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, and WI.

    Quantity

    220 units