BEUDAMED
    FDA Recall Terminated

    Stryker Endoscopy brand 3.5mm Super 90-S SERFAS Energy Suction Probe; Model Number: 279-351-300; Manufactured By: Stryker Endoscopy, Puerto Rico

    Recall: Z-0972-2009 · Initiated June 20, 2008

    Recall

    Recall Number
    Z-0972-2009
    Event Number
    50825
    Firm
    Stryker Endoscopy
    FEI Number
    2936485
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 20, 2008
    Posted
    February 9, 2009
    Terminated
    June 22, 2009
    Address
    5900 Optical Ct, San Jose, CA, 95138-1400

    Description

    Stryker Endoscopy brand 3.5mm Super 90-S SERFAS Energy Suction Probe; Model Number: 279-351-300; Manufactured By: Stryker Endoscopy, Puerto Rico

    Reason

    The probes may have inadequate suction due to obstruction, which can result in unintended ablation due to reduced visibility within the surgical area.

    Action

    On 6/20/08, the firm initiated the recall and its notification was via Urgent: Device Removal letters explaining the reason for the recall. The letter recommended that recipients of the letter inspect their inventory for the part number/lot numbers listed and quarantine any of the affected product. Affected products should be returned to Stryker Endoscopy using the Pre-paid shipping label provided. Customers should call Stryker Endoscopy's Customer Service Department at 1-800-624-4422 for replacement product. Importantly, customers should sign and complete the enclosed "acknowledgment of receipt" card and return it to Stryker Endoscopy or fax it to 408-754-2521 with the customer's account info included. If there are any questions regarding the notice, a Regulatory Affairs Representative should be contacted at 408-754-2161 or 408-754-2000.

    Distribution

    Worldwide Distribution.

    Quantity

    2463 units