BEUDAMED
    FDA Recall Terminated

    Stratum MDS Screw 3.5x46mm ST Part Number: STRM-MDS-3546ST

    Recall: Z-0776-2020 · Initiated November 11, 2019

    Recall

    Recall Number
    Z-0776-2020
    Event Number
    84405
    Firm
    Nextremity Solutions
    FEI Number
    3009540749
    Product Code
    HWC
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    November 11, 2019
    Terminated
    September 10, 2020
    Address
    6210 N Buffalo St, Warsaw, IN, 46580

    Description

    Stratum MDS Screw 3.5x46mm ST Part Number: STRM-MDS-3546ST

    Reason

    Components 2mm shorter than indicated on the package label

    Action

    Nextremity Solutions issued Urgent Medical Device Recall letter on 11/11/19 stating reason for recall, health risk and action to take: do not use, quarantine and return to Zimmer Biomet representative who will remove product, Contact customer service at 574-371-3071 between 8am -5pm(EST) M-F.

    Distribution

    Nationwide

    Quantity

    87 units