BEUDAMED
    FDA Recall Terminated

    Stryker brand Consolidated Operating Room Equipment (CORE) SystemPowered Instrument Driver, REF 5400-50; Model 5400-050-000A.

    Recall: Z-1390-05 · Initiated August 5, 2005

    Recall

    Recall Number
    Z-1390-05
    Event Number
    32845
    Firm
    Stryker Instruments Div. of Stryker Corporation
    FEI Number
    1811755
    Product Code
    DZJ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 5, 2005
    Posted
    August 23, 2005
    Terminated
    October 26, 2005
    Address
    4100 E. Milham, Kalamazoo, MI, 49001

    Description

    Stryker brand Consolidated Operating Room Equipment (CORE) SystemPowered Instrument Driver, REF 5400-50; Model 5400-050-000A.

    Reason

    Potential electrical shock hazard, in that the potential exists for the patient to be exposed to an earth-referenced electrical current.

    Action

    U.S. customer was notified via recall letter dated August 5, 2005 and international affiliates were notified via email. U.S. account was requested to return the product.

    Distribution

    Virginia, Australia, Canada, England, France, Germany, Japan, Netherlands, Sweden, Switzerland,

    Quantity

    27