BEUDAMED
    FDA Enforcement Class II Terminated

    ConForMIS Unicondylar Knee Replacement System iUNI G2, Left Medial Catalog Number: M57220600210(US) M5722INT0600210 (OUS)

    Recall: Z-0139-2016 · Reported October 28, 2015

    Enforcement

    Recall Number
    Z-0139-2016
    Event ID
    72108
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ConforMIS, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    October 28, 2015
    Initiation Date
    August 31, 2015
    Classification Date
    October 21, 2015
    Termination Date
    March 2, 2016
    Address
    28 Crosby Dr, N/A, Bedford, MA, 01730-1402, United States

    Description

    ConForMIS Unicondylar Knee Replacement System iUNI G2, Left Medial Catalog Number: M57220600210(US) M5722INT0600210 (OUS)

    Reason

    May contain small amounts of ethylene glycol residue

    Code Info

    Serial Numbers (US): 0353901 0354506 0354220 0355550 0355016 0350789 0354111 0354321 0352939 0353154 0353812 0354828 0354576 0354180 0355588 0355064 0353912 0351237 0351983 0354434 0353374 0351642 0352751 0355557 0353757 0353944 0354218 0353846 0353688 0355110 0352483 0345608 0353771 0353306 3054517 Serial Numbers (OUS): 0348705 0349592 0351522 0351616 0352700 0352750 0352827 0352840 0352999 0353210 0353225 0353263 0353420 0353514 0353515 0353577 0353714 0353791 0353822 0353918 0353921 0354163 0354208 0354284 0354292 0354439 0354507 0354509 0354605 0354771 0354773 0354792 0355178 0355188 0355202 0355227

    Distribution

    Distributed Nationwide and in Germany, Switzerland, and UK.

    Quantity

    71 units