BEUDAMED
    FDA Recall Terminated

    Stryker Endoscopy 3.55 MM Super 90 S-SERFAS Energy Probe; electrosurgical device. Model number: 279-351-300;

    Recall: Z-0265-2012 · Initiated October 24, 2011

    Recall

    Recall Number
    Z-0265-2012
    Event Number
    60301
    Firm
    Stryker Endoscopy
    FEI Number
    2936485
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    October 24, 2011
    Posted
    November 21, 2011
    Terminated
    February 29, 2012
    Address
    5900 Optical Ct, San Jose, CA, 95138-1400

    Description

    Stryker Endoscopy 3.55 MM Super 90 S-SERFAS Energy Probe; electrosurgical device. Model number: 279-351-300;

    Reason

    An increased number of complaints for tip breaks were observed for the 3.5mm Super 90-S SERFAS Energy Suction Probes manufactured from June to August 2011.

    Action

    Stryker Endoscopy Urgent Medical Device Removal notifications datyed October 25, 2011, were sent to all consignees via traceable mail. Sales representatives and regional managers were notified by e-mail. Product is to be returned to Stryker Endoscopy using the pre-paid shipping label. Replacement product may be obtained by calling Stryker at 1-800-624-4422. The enclosed Acknowledgement receipt form is to be completed and returned. Questions or comments may be directed to Stryker at 1-800-624-4422 or e-mail at [email protected].

    Distribution

    Worldwide distribution including USA, Australia, Canada, China, Greece, Hong Kong, India, Italy, Japan, France, Netherlands, Poland, South Africa, Spain, Sweden, Switzerland and the United Kingdom

    Quantity

    6307