BEUDAMED
    FDA Recall Terminated

    Stryker brand Intra-Compartmental (STIC) Pressure Monitor, Model 295-001-000.

    Recall: Z-0034-06 · Initiated July 22, 2005

    Recall

    Recall Number
    Z-0034-06
    Event Number
    32842
    Firm
    Stryker Instruments Div. of Stryker Corporation
    FEI Number
    1811755
    Product Code
    LXC
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 22, 2005
    Posted
    October 12, 2005
    Terminated
    February 15, 2006
    Address
    4100 E. Milham, Kalamazoo, MI, 49001

    Description

    Stryker brand Intra-Compartmental (STIC) Pressure Monitor, Model 295-001-000.

    Reason

    The pressure indicated may be inaccurate, and this inaccuracy may be not detectable by the user.

    Action

    Consignees were notified by recall letter dated August 5, 2005 to locate the affected serial numbers and to return the product to the firm.

    Distribution

    Nationwide, Argentina, Australia, Canada, Costa Rica, England, France, Germany, Hong Kong, India, Indonesia, Japan, Netherlands, New Zealand, South Africa, Spain, Sweden, Switzerland, Taipei, Turkey and United Arab Emir.

    Quantity

    473