BEUDAMED
    FDA Enforcement Class II Terminated

    Comprehensive RS Cleat CAP, Item No. 110300

    Recall: Z-0525-2020 · Reported December 4, 2019

    Enforcement

    Recall Number
    Z-0525-2020
    Event ID
    83783
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 4, 2019
    Initiation Date
    August 21, 2019
    Classification Date
    November 22, 2019
    Termination Date
    July 21, 2021
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989, United States

    Description

    Comprehensive RS Cleat CAP, Item No. 110300

    Reason

    Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.

    Code Info

    126590 126600 502890 502900 502910 012080 941080

    Distribution

    US Nationwide distribution and countries of Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecuador, El Salvador, Italy, Netherlands, India, Japan, Korea, Malaysia, Mexico, New Zealand, Panama, Singapore, Taiwan, Thailand, Trinidad and Tobago, and Venezuela.

    Quantity

    219988 units (total)