BEUDAMED
    FDA Recall Terminated

    Tessier Osseous Microtome TOM(R) Bone Mill, 01-15402, Stryker Portage, MI. The TOM bone mill is designed to grind any type of cortical or cancellous bone.

    Recall: Z-1202-2010 · Initiated February 18, 2010

    Recall

    Recall Number
    Z-1202-2010
    Event Number
    54663
    Firm
    Stryker Craniomaxillofacial Division
    FEI Number
    3005101424
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Equipment maintenance
    Initiated
    February 18, 2010
    Posted
    March 23, 2010
    Terminated
    November 24, 2010
    Address
    750 Trade Centre Way, Ste 200, Portage, MI, 49002-0482

    Description

    Tessier Osseous Microtome TOM(R) Bone Mill, 01-15402, Stryker Portage, MI. The TOM bone mill is designed to grind any type of cortical or cancellous bone.

    Reason

    The firm has received 328 customer complaints for this device. Most of the complaints were involving non-functioning of the ratcheting handle or complete device, or the presence of metal shavings or discoloration.

    Action

    An "URGENT MEDICAL DEVICE CORRECTION" letter dated February 18, 2010, was sent to the customers. The letter describes the product, problem, scope of affected products, potential patient risks and actions to be taken by the customers. The customers should review the letter with all users of the TOM(r) Bone Mill and follow the instructions on the proper inspection and maintenance of the device enclosed with the letter. The customers should fax the accountability form within 5 days to help Stryker ensure their receipt of the information. If the accountability form is not received, addition communication will be sent. If you have any urgent questions or concerns, please contact us at (269) 323-4258. Please ref: PFA #2009-128. Our normal business hours are Monday-Friday 8am-5pm (GMT+1:00) On 7/8/2010 the firm sent an Urgent Medical Device Recall letter to its customers. The letter stated thatt upon consultation with regulatory agencies outside of the United States, the firm had intiated a devicd removal. The letter instructed the customers to return any devices that they had to the recalling firm.

    Distribution

    Worldwide distribution: USA and Belarus, Bulgaria, Denmark, Finland, Hungary, Jordan, Norway, Russia, Saudi Arabia and the UAE.

    Quantity

    596 units