BEUDAMED
    FDA Enforcement Class II Terminated

    Catalog 314-13-33, Equinoxe Cage Glenoid, Posterior Augment, Right, Medium

    Recall: Z-0460-2021 · Reported November 25, 2020

    Enforcement

    Recall Number
    Z-0460-2021
    Event ID
    86630
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Exactech, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 25, 2020
    Initiation Date
    October 6, 2020
    Classification Date
    November 17, 2020
    Termination Date
    November 13, 2023
    Address
    2320 NW 66th Ct, N/A, Gainesville, FL, 32653-1630, United States

    Description

    Catalog 314-13-33, Equinoxe Cage Glenoid, Posterior Augment, Right, Medium

    Reason

    The product may be mislabeled.

    Code Info

    Catalog 314-13-33, Serial Numbers: 6259572 6259573 6259575 6259577 6259578 6259579 6259583 6259584 6259587 6259588 6259590 6259591 6259592 6259594 6259595 6132993 6132994 6132995 6132996 6132997 6132998 6132999 6133000 6133002 6133003 6133005 6133008 6133009 6133010 6133011 6133013 6133014 6133017 6133020 6133021 6133023 6133029 6133030 6133031 6133032

    Distribution

    US consignees - AZ, CA, CO, FL, IL, IN, KY, LA, OH, OK, MD, ME, MN, NV, NY, SC, TN, TX, VA, WA, WI International consignees - Australia, Japan, and United Kingdom

    Quantity

    40 devices