BEUDAMED
    FDA Recall Terminated

    Stryker Cordless Driver 3 Handpiece. Stryker Instruments, Kalamazoo, MI; REF 4300. The device is intended for use in surgical procedures involving drilling, reaming, driving wire or pins, and cutting bone and hard tissue.

    Recall: Z-1021-2009 · Initiated October 10, 2008

    Recall

    Recall Number
    Z-1021-2009
    Event Number
    50084
    Firm
    Stryker Instruments Div. of Stryker Corporation
    FEI Number
    1811755
    Product Code
    KIJ
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    October 10, 2008
    Posted
    March 10, 2009
    Terminated
    October 27, 2010
    Address
    4100 E Milham Ave, Portage, MI, 49002

    Description

    Stryker Cordless Driver 3 Handpiece. Stryker Instruments, Kalamazoo, MI; REF 4300. The device is intended for use in surgical procedures involving drilling, reaming, driving wire or pins, and cutting bone and hard tissue.

    Reason

    The handpieces may continue to run even when the trigger is not depressed, which could result in the unintended cutting of bone or soft tissue damage.

    Action

    Consignees were notified of the problem via letter dated October 10, 2008, provided interim instructions to reduce the risk, and informed that Stryker instruments will replace the trigger on all handpieces. Consignees were also instructed on the following: 1) Review the letter and distribute to all affected departments, 2) Complete and sign the enclosed Business Reply Form and fax to 336-499-8603 and 3) Call Stryker Instruments Service Department at 888-308-1983 to schedule service for the handpieces.

    Distribution

    Worldwide Distribution including USA and countries of Australia, Brazil, Canada, Chile, Colombia, Costa Rica, England, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Pakistan, Panama, Peru, Philippines, Poland, Romania, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan and Turkey.

    Quantity

    25,312 of all units