BEUDAMED
    FDA Recall Open, Classified

    Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number: 6191-0-001

    Recall: Z-0736-2023 · Initiated November 7, 2022

    Recall

    Recall Number
    Z-0736-2023
    Event Number
    91147
    Firm
    Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    LOD
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    November 7, 2022
    Posted
    December 20, 2022
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2006

    Description

    Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number: 6191-0-001

    Reason

    Instructions for Use (IFU) included in the packaging is missing a translation in the Turkish language. Although the Turkish translation is missing, all content within the IFUs is accurate.

    Action

    Update 12/15/22: An UPDATED Urgent Medical Device Correction PFA 3140774 was issued to impacted customers in Turkey only on December 15, 2022. Letter states: 1. Please inform users of this UPDATE Urgent Medical Device Correction and forward this notice to all individuals who need to be made aware. 2. Go to link https://ifu.stryker.com/ and follow instructions for Figures 1 and 2 for the electronic version of the Turkish translated Instructions for Use for affected product outlined in Table 1. 3. Complete and sign the enclosed UPDATE Urgent Medical Device Correction Business Reply Form. Potential Harm: There are no identified harms associated with this issue which would lead to any known adverse health consequences. Please assist us in meeting our regulatory obligation by emailing back the attached UPDATE Urgent Medical Device Correction Business Reply Form within 5 days. A response is required, even though you may not have any physical inventory on site. please contact Customer Service at (888)-756-7846. For questions pertaining to the recall, email [email protected]. ____________________________________________________________________________ Stryker issued Urgent Medical Device Correction PFA 3140774 to customers in Turkey only via Stryker sales representatives on Nov. 16, 2022. Letter states reason for recall and action to take: 1. Please inform users of this Urgent Medical Device Correction and forward this notice to all individuals who need to be made aware. 2. Go to link https://ifu.stryker.com/ and follow instructions for Figures 1 and 2 for the electronic version of the Turkish translated Instructions for Use for affected product outlined in Table 1. 3. Complete and sign the enclosed Urgent Medical Device Correction Business Reply Form.

    Distribution

    International distribution in the country of Turkey.

    Quantity

    2085 units