BEUDAMED
    FDA Recall Terminated

    Stryker Stiletto Electrosurgical Probe (E-Probe); Model number: 0270-070-550, 0270-070-551, 0270-070-552, 0270-070-553, 0270-070-554, 0270-070-555; Manufactured by Stryker Endoscopy Puerto Rico.

    Recall: Z-1704-2011 · Initiated February 25, 2010

    Recall

    Recall Number
    Z-1704-2011
    Event Number
    55617
    Firm
    Stryker Endoscopy
    FEI Number
    2936485
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 25, 2010
    Posted
    March 17, 2011
    Terminated
    March 18, 2011
    Address
    5900 Optical Ct, San Jose, CA, 95138-1400

    Description

    Stryker Stiletto Electrosurgical Probe (E-Probe); Model number: 0270-070-550, 0270-070-551, 0270-070-552, 0270-070-553, 0270-070-554, 0270-070-555; Manufactured by Stryker Endoscopy Puerto Rico.

    Reason

    The heat shrink, PTFE E-Probe Tip were out of specification (OOS) in the longitudinal change (+5% -20%).

    Action

    All Sales reps were notified of the recall on February 25, 2010. Urgent Device Removal advisory notices were also sent to all consignees.Device Removal letters identified the specific part numbers and lot numbers involved. Letters also list the potential risk to patients as a result of the issue. Customers are asked to inspect their inventory for part and lot numbers and quarantine any affected product. If recalled product is found, customers are to contact Stryker Customer Service at 800-624-4422 and request an RMS to send back recalled units. New units will be provided at no charge. The acknowledgement form is to be completed and returned. Questions or concerns should be directed to 408-754-2000 or e-mail at [email protected].

    Distribution

    Worldwide Distribution -- US, Australia, Canada, Germany, Greece, Iberia, Korea, Switzerland, and Newbury.

    Quantity

    31, 014 units