BEUDAMED
    FDA Recall Terminated

    Stryker Disposable StrykeProbe 32cm L- Tip, Ref: 250-070-550, Electrosurgical Suction Tip, Stryker Endoscopy, San Jose, CA 95138.

    Recall: Z-0573-2008 · Initiated November 16, 2007

    Recall

    Recall Number
    Z-0573-2008
    Event Number
    45881
    Firm
    Stryker Endoscopy
    FEI Number
    2936485
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 16, 2007
    Posted
    March 5, 2008
    Terminated
    March 26, 2008
    Address
    5900 Optical Ct, San Jose, CA, 95138

    Description

    Stryker Disposable StrykeProbe 32cm L- Tip, Ref: 250-070-550, Electrosurgical Suction Tip, Stryker Endoscopy, San Jose, CA 95138.

    Reason

    Cannot connect: Tips have electrodes that are too large to fit monopolar cables and are unusable.

    Action

    Stryker notified their sales representatives by phone. Stryker sent all consignees a Product Advisory Notice dated November 19, 2007, and verbally notified them of the recall via telephone. A response form with return postage was sent with the notice. The letter requested the hospitals to quarantine and return the product to Stryker.

    Distribution

    Nationwide Distribution.

    Quantity

    59 boxes of 6 units (354 total)