BEUDAMED
    FDA Enforcement Class II Terminated

    Sutures. MAXON: MAXON 4/0 5X18" GREEN CV-24 D-TACH; Item Number: 8886621933; MAXON 5/0 5X18 GR CV-23 D-TACH; Item Number: XX2109; MAXON* 4/0 5X30 GREEN V-20 D*TACH; Item Number: 8886603433

    Recall: Z-2542-2017 · Reported June 21, 2017

    Enforcement

    Recall Number
    Z-2542-2017
    Event ID
    77144
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 21, 2017
    Initiation Date
    May 3, 2017
    Classification Date
    June 14, 2017
    Termination Date
    July 18, 2019
    Address
    60 Middletown Ave, N/A, North Haven, CT, 06473-3908, United States

    Description

    Sutures. MAXON: MAXON 4/0 5X18" GREEN CV-24 D-TACH; Item Number: 8886621933; MAXON 5/0 5X18 GR CV-23 D-TACH; Item Number: XX2109; MAXON* 4/0 5X30 GREEN V-20 D*TACH; Item Number: 8886603433

    Reason

    Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.

    Code Info

    MAXON 4/0 5X18" GREEN CV-24 D-TACH D4K0396X D4K2053X D4L0541X D4L1084X D4L1272X D4M0394X MAXON 5/0 5X18 GR CV-23 D-TACH D4K1485X MAXON* 4/0 5X30 GREEN V-20 D*TACH D4L1156GX

    Distribution

    Worldwide distribution. US Nationwide including PR, and countries of AU, BE, CA, CL, CN, IL, IT, JP, KR, MX, PA, SA, SG, and TR.

    Quantity

    478,465 (total for all products)