BEUDAMED
    FDA Recall Terminated

    Stryker SmartLife Large Aseptic Housing REF 7126-120-000 Rx Only The SmartLife" Aseptic Housings are designed to be used in conjunction with the SmartLife Non-Sterile Batteries to provide power for System 7 Handpieces, Cordless Driver 4 Handpiece, and Sabo2 Sagittal Saw Handpiece.

    Recall: Z-0172-2015 · Initiated October 8, 2014

    Recall

    Recall Number
    Z-0172-2015
    Event Number
    69382
    Firm
    Stryker Instruments Div. of Stryker Corporation
    FEI Number
    1811755
    Product Code
    HWE
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 8, 2014
    Posted
    November 5, 2014
    Terminated
    May 31, 2016
    Address
    4100 E Milham Ave, Portage, MI, 49002-9704

    Description

    Stryker SmartLife Large Aseptic Housing REF 7126-120-000 Rx Only The SmartLife" Aseptic Housings are designed to be used in conjunction with the SmartLife Non-Sterile Batteries to provide power for System 7 Handpieces, Cordless Driver 4 Handpiece, and Sabo2 Sagittal Saw Handpiece.

    Reason

    The SmartLife Aseptic Housings are being recalled in that the top section of the housing may separate from the bottom section due to insufficient welding.

    Action

    On October 8, 2014, Stryker Instruments issued "URGENT MEDICAL DEVICE RECALL NOTIFICATION" to their consignees. Notification included affected product description, reason for recall, risk to health, and actions to be taken by the customer/user. The customer/user were instructed to immediately review this recall notification, check all stock areas; discontinue use of any product which shows sign of cracking or damage at the weld; and complete and return the enclosed Business Reply Form (BRF) via fax to Stryker Instruments Regulatory Department, 866-521-2762 or scan and email a copy to [email protected]. Upon receipt of completed BRF, a replacement product will be shipped and the customer/users, upon receipt of replacement product, are to remove and return all recalled product from use and replace them with new product. For questions regarding this recall, please contact Stryker Instruments: at 269-389-4518 or email: [email protected].

    Distribution

    Worldwide Distribution: US (nationwide) WI, MD, NY, NM, AZ, GA, CA, MN, DE, PA, TX, MT, MI, KS, KY, WY, IL; and countries of: Australia, Canada, Sweden, Netherlands, France Switzerland, India, Japan, Poland, South Africa, England, and Hong Kong.

    Quantity

    3,138 in total