BEUDAMED
    FDA Recall Open, Classified

    Yukon Straight Rod 4.0 x120mm; Cat# 7601-540120. Used to provide immobilization and stabilization of spinal segments.

    Recall: Z-1307-2022 · Initiated June 13, 2022

    Recall

    Recall Number
    Z-1307-2022
    Event Number
    90462
    FEI Number
    3008599177
    Product Code
    KWP
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    June 13, 2022
    Address
    K2M Inc. 600 Hope Pkwy Se, Leesburg, VA, 20175-4428

    Description

    Yukon Straight Rod 4.0 x120mm; Cat# 7601-540120. Used to provide immobilization and stabilization of spinal segments.

    Reason

    Some of the rods in this lot were observed to have discoloration, later confirmed to be indication of trace amounts of inorganic phosphorous compound. This may produce a mild irritating or inflammatory response; adverse local tissue reactions may occur related to cytotoxicity with the nonconforming rod and surrounding tissue.

    Action

    On June 13, 2022, the firm distributed Medical Device Recall letters to affected customers. Customers were informed that local Stryker Sales Representative or Stryker Branch or Agency has already removed any product still located in customer facilities at the time of the initiation of the removal. If you have any questions or concerns, please contact Regulatory Compliance at 201.749.8090.

    Distribution

    Domestic distribution to FL GA NE NV NY OH OK SC Foreign distribution to Canada, EU, and Hong Kong.

    Quantity

    53 devices (19 US; 34 OUS)