BEUDAMED
    FDA Recall Terminated

    Aequalis Fx2 implant parts and instrument trays. Insert component : Part Numbers DWK204B-DWK206B, DWK224B-DWK226B, DWK230B-DWK23B, DWK244B-DWK246B, DWK250B-DWK252B, DWK264B-DWK266B, DWK270B-DWK272B. Stem Component: Part Number: DWK111B-DWK115B, DWK121B-DWK126B, DWK131B-DWK135B. Product Usage: Total or partial replacement of the Gleno-humeral articulation.

    Recall: Z-0699-2017 · Initiated September 19, 2016

    Recall

    Recall Number
    Z-0699-2017
    Event Number
    75444
    Firm
    Tornier, Inc
    FEI Number
    3000718467
    Product Code
    KWS
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    September 19, 2016
    Terminated
    May 31, 2018
    Address
    10801 Nesbitt Ave S, Bloomington, MN, 55437-3109

    Description

    Aequalis Fx2 implant parts and instrument trays. Insert component : Part Numbers DWK204B-DWK206B, DWK224B-DWK226B, DWK230B-DWK23B, DWK244B-DWK246B, DWK250B-DWK252B, DWK264B-DWK266B, DWK270B-DWK272B. Stem Component: Part Number: DWK111B-DWK115B, DWK121B-DWK126B, DWK131B-DWK135B. Product Usage: Total or partial replacement of the Gleno-humeral articulation.

    Reason

    Tornier is conducting a recall on Aequalis Fx2 ( implant parts and instrument trays) due to reports of dislocations of the poly insert and the stem.

    Action

    Wright sent an "Urgent Medical Device Recall" letter dated September 19, 2016. The letter was addressed to Healthcare Professional. The letter identified the affected product, problem and actions to be taken. It advised consignees to stop further distribution or use of product immediately. Requires consignees to notify all accounts that may be end-users, or contact Wright with your request for us to contact them. Advised consignee to complete and e-mail the attached questionnaire to [email protected]. For questions contact the same.

    Distribution

    US Distribution TX, CA, and MI

    Quantity

    30