BEUDAMED
    FDA Recall Terminated

    Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories. These burs are intended for use during various surgical procedures to cut hard tissue or bone and soft tissue. More specifically these burs are used for shaping the bone (femur) during orthopedic surgeries.

    Recall: Z-1235-2011 · Initiated November 30, 2010

    Recall

    Recall Number
    Z-1235-2011
    Event Number
    57505
    Firm
    Stryker Instruments Division of Stryker Corporation
    FEI Number
    1811755
    Product Code
    HBE
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    November 30, 2010
    Posted
    February 14, 2011
    Terminated
    April 13, 2011
    Address
    4100 East Milham Ave., Kalamazoo, MI, 49001

    Description

    Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories. These burs are intended for use during various surgical procedures to cut hard tissue or bone and soft tissue. More specifically these burs are used for shaping the bone (femur) during orthopedic surgeries.

    Reason

    Product was packaged with an incorrect packaging material and therefore has a potential to be non-sterile which, if contaminated, could lead to a patient infection.

    Action

    The firm, Stryker, sent a "MEDICAL DEVICE RECALL NOTIFICATION" letter dated December 2, 2010 to all customers. The letter described the product, problem and the action to be taken by the customers. The customer were asked to complete and fax in the business reply form indicating they have received the notification and to indicate whether or not they have affected product on hand, and send back any affected product to Regulatory Affairs at Stryker Instruments. Stryker will then send a replacement product to the customer. Upon receipt of the completed business reply form, the customer will be contacted to arrange return of any affected product they have in their inventory. Once the affected product is received, a replacement 5190 TPS Series Bur will be sent to the customer. For questions regarding this recall, please contact Stryker Instruments at 1-800-800-4236 ext. 3584 or [email protected].

    Distribution

    Worldwide distribution: USA including states of: CA, FL, LA, MI, MT, NE, NH, OH, PA, SD, TN, TX, VT, and WA; and countries including: Sweden and Australia.