BEUDAMED
    FDA Recall Terminated

    TC-PLUS Solution Femoral Component Size 12L, part 21041-C, lot 0006.13.2635.

    Recall: Z-0170-04 · Initiated September 9, 2002

    Recall

    Recall Number
    Z-0170-04
    Event Number
    25007
    Firm
    Plus Orthopedics
    FEI Number
    3001237832
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 9, 2002
    Posted
    November 27, 2003
    Terminated
    December 30, 2003
    Address
    6055 Lusk Blvd, San Diego, CA, 92121

    Description

    TC-PLUS Solution Femoral Component Size 12L, part 21041-C, lot 0006.13.2635.

    Reason

    Inaccurate dimensions of the device. Offshore manufacturer recalled product, some of which have been implanted.

    Action

    Certified letters were sent out to the 2 providers that had implanted the device. The remaining inventory was exported back to the manufacturer.

    Distribution

    TX,

    Quantity

    5