BEUDAMED
    FDA Enforcement Class II Terminated

    Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO.

    Recall: Z-1031-2016 · Reported March 9, 2016

    Enforcement

    Recall Number
    Z-1031-2016
    Event ID
    73201
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mako Surgical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 9, 2016
    Initiation Date
    January 15, 2016
    Classification Date
    March 1, 2016
    Termination Date
    August 6, 2019
    Address
    2555 Davie Rd Ste 110, N/A, Plantation, FL, 33317-7424, United States

    Description

    Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO.

    Reason

    Reports where the Mylar/Tyvek pouch for RESTORIS MCK Baseplate in the clamshell packaging configuration exhibited damage, compromising the sterile barrier.

    Code Info

    Catalog # 180601 - Lot #'s: 26110111, 26300512-01, 26110112-01, and 26090311-01 Catalog # 180602 - Lot #'s: LET1484311012, 26020812-01, 26220512-01, 26180711-0126120211-01, 26301011-01, 26161111-01, and 26220512-02. Catalog # 180603 - Lot #'s: LET 1388860512, 26010511-01, 26310811-01 and 26050112-01 Catalog # 180604 - Lot #'s: 26090512-01 and 26280412-01 Catalog # 180605 - Lot #'s: 26310512-01, 26270512-01, and 26250511-01 Catalog # 180606 - Lot #'s: LET1464570912, 26300412-01, 26140412-01, and 26050212-01. Catalog # 180607 - Lot #'s: 26211011-01, 26040212-01, 26330512-01, 26090611-02, 26070811-01, LET1406460512, and 26230411-01. Catalog # 180608 - Lot # 26141111-01 Catalog # 180611 - Lot #'s 26131111-01 and 26050211-01 Catalog # 180612 - Lot #'s 26190911-01, 36010112-1, 26070212-01, 26410611-01, 26020411-01, and 26060211-01 Catalog # 180613 Lot #'s 26271011-01 and 26240711-01 Catalog # 180614 - Lot #'s 36031211-1, 26180512-01, 26440611-01, and 26190612-01 Catalog # 180615 Lot # 2610012-01 Catalog # 180616 Lot #'s 26160212-01, 2634012-01, 26300811-01, 26171111-01, 26350512-01, and 26310612-01. Catalog # 180617 Lot #'s 26310412-01, 26160711-01, 26210511-02, 26061011-01, 26061011-01, and LOT1388810512. Catalog # 180618 Lot #'s: 26360512-01, 26060311-01, and 26061211-01.

    Distribution

    Worldwide Distribution: US (nationwide) including states of: AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, LA, MI, MS, MO, NC, NH, NJ, NV, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, WA, WI, and WY ; and countries of: Italy, Scotland, Turkey, Greece, Germany, and Singapore.

    Quantity

    146